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 3 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Nova Biomedical with 129 510(k) clearances and 24 device recalls. The most recent is a device recall dated Jul 29, 2026: StatStrip Glucose and B- Ketone meter. Model No: 63910. Glucose test system..
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.
| Date | Record | Source |
|---|---|---|
| Jul 29, 2026 | StatStrip Glucose and B- Ketone meter. Model No: 63910. Glucose test system.Class I · A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the de | Device recalls |
| Jul 29, 2026 | StatStrip Glucose and B- Ketone meter. Model No: 63683. Glucose test system.Class I · A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the de | Device recalls |
| Jul 29, 2026 | StatStrip Glucose Hospital Meter System. Model No: 63685. Glucose test system.Class I · A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the de | Device recalls |
| Jul 29, 2026 | StatStrip Glucose and B- Ketone meter. Model No: 66429. Glucose test system.Class I · A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the de | Device recalls |
| Jul 29, 2026 | StatStrip Glucose Hospital Meter System. Model No: 66739. Glucose test system.Class I · A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the de | Device recalls |
| Jan 21, 2026 | Nova Max Creat eGFR Monitoring SystemK251281 · SHB | 510(k) clearances |
| Jan 9, 2026 | Nova Allegro UACR Assay, Nova Allegro AnalyzerK252206 · CGX | 510(k) clearances |
| Nov 22, 2024 | Nova Allegro HbA1c Assay, Nova Allegro AnalyzerK221326 · LCP | 510(k) clearances |
| Nov 20, 2024 | StatStrip Glucose Hospital Meter System. Model/Catalog Number: 63685. Prescription use blood glucose meter for near-patient testing.Class I · A software bug within the Gen 2 StatStrip Hospital Meter firmware leads to transmission of erroneous glucose patient tes | Device recalls |
| Nov 20, 2024 | StatStrip Glucose Ketone (mmol/L) Hospital Meter System. Model/Catalog Number: 63910. Prescription use blood glucose ketone meter for near-pClass I · A software bug within the meter firmware leads to transmission of erroneous glucose and/or ketone patient test results t | Device recalls |
| Nov 20, 2024 | StatStrip Glucose Ketone Hospital Meter System. Model/Catalog Number: 63683. Prescription use blood glucose ketone meter for near-patient teClass I · A software bug within the meter firmware leads to transmission of erroneous glucose and/or ketone patient test results t | Device recalls |
| Nov 19, 2024 | Nova Allegro UACR Assay, Nova Allegro AnalyzerK221813 · CGX | 510(k) clearances |
| Feb 23, 2024 | StatStrip Glucose Hospital Meter SystemK232075 · PZI | 510(k) clearances |
| Sep 29, 2023 | Stat Profile Prime Plus Analyzer SystemK221900 · CHL | 510(k) clearances |
| Oct 18, 2022 | Nova Primary Glucose Analyzer SystemK203549 · CGA | 510(k) clearances |
| Apr 14, 2020 | Stat Profile Prime Plus Analyzer SystemK200403 · JGS | 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
