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., part of WerfenLabelled by claude-sonnet-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 Accriva Diagnostics, Inc. with 7 device recalls and 3 510(k) clearances. The most recent is a 510(k) clearance dated Mar 2, 2023: Tenderfoot.
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 |
|---|---|---|
| Mar 2, 2023 | TenderfootK223352 · FMK | 510(k) clearances |
| Dec 29, 2021 | GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+), GEM Hemochron 100 Low Range Activated Clotting Time Test (ACT-LR), directCHECK ACT+ Whole Blood Control, Level 1 and Level 2, directCHECK ACT-LR Whole Blood Control, Level 1 and Level 2K202101 · JPA | 510(k) clearances |
| Nov 22, 2019 | Hemochron Signature EliteK193041 · JPA | 510(k) clearances |
| Apr 22, 2016 | Accriva- APTT Cuvette for use on the Hemochron Jr. test system, catalog #J103, lot B6JCA012.Class II · Clot activating reagent mis-positioned or visibly absent in the cuvette's test channel causing APTT test to either have | Device recalls |
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
