Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Stanbio Laboratory with 47 510(k) clearances and 9 device recalls. The most recent is a device recall dated Oct 2, 2023: STAT-Site M BHB Test Strips, used with STAT-SITE M Beta-HB Meter as an in vitro diagnost….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Oct 2, 2023 | STAT-Site M BHB Test Strips, used with STAT-SITE M Beta-HB Meter as an in vitro diagnostic for blood ketone values.Class II · Deterioration in the stability of the Test Strips results in diminished low-range detection capability and inability to | Device recalls |
| Mar 16, 2022 | Separation Technology Creamatocrit Plus, Catalog Number: 100-146Class II · The device was being marketed as an IVD without a 510(k). Therefore, performance characteristics of these breast milk an | Device recalls |
| Jul 12, 2021 | Beta-Hydroxybutyrate Reagent A - Enzyme (unlabeled). in vitro diagnostic reagent.Class III · Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control | Device recalls |
| Jul 12, 2021 | Synchron CX/DX/LX Beta-Hydroxybutyrate . in vitro diagnostic reagent.Class III · Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control | Device recalls |
| Jul 12, 2021 | Cardinal Health Beta-Hydroxybutyrate . in vitro diagnostic reagent.Class III · Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control | Device recalls |
| Jul 12, 2021 | Beta-Hydroxybutyrate LiquiColor. in vitro diagnostic reagent.Class III · Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control | Device recalls |
| Jul 12, 2021 | Cardinal Health Beta-Hydroxybutyrate LiquiColor for Synchron CX/LX/DX. in vitro diagnostic reagent.Class III · Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control | Device recalls |
| Feb 8, 2018 | Stanbio AC power adapter for the HemoPoint H2 meter, Model G3000 series. The firm name on the label for the HemoPoint H2 shows ManufacturedClass II · The US prong (type A) adapter plate may crack, break, or detach and remain in the electrical outlet exposing live electr | Device recalls |
| Jun 10, 2009 | STANBIO LABORATORY HEMOPOINT H2 DM HEMOGLOBIN MEASUREMENT SYSTEMK090093 · GKR | 510(k) clearances |
| Jul 18, 2008 | STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEMK081719 · GKR | 510(k) clearances |
| Jun 30, 2005 | CREATININE LIQUICOLORK050283 · JFY | 510(k) clearances |
| Jun 30, 2005 | DIRECT BILIRUBIN LIQUICOLOR AND TOTAL BILIRUBIN LIQUICOLORK050266 · JFM | 510(k) clearances |
| Mar 14, 2005 | STANBIO LABORATORY SIRRUS CLINICAL CHEMISTRY ANALYZERK042169 · JJE | 510(k) clearances |
| Oct 14, 2004 | WIDE RANGE C-REACTIVE PROTEIN (WR CRP) ASSAYK041155 · DCK | 510(k) clearances |
| Mar 12, 2004 | DIRECT LDL CHOLESTEROL LIQUID COLOR AND STANBIO DIRECT HDL/LDL CHOLESTEROL CALIBRATORK032936 · JIX | 510(k) clearances |
| Mar 10, 2004 | DIRECT HDL-CHOLESTEROL LIQUID COLOR; DIRECT HDL/LDL-CHOLESTEROL CALIBRATORK032932 · LBS | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
