510(k) K910706 ยท GHR Reagent, Platelet Aggregation
COLLAGEN REAGENT CAT. NO. 5368
| Applicant | Helena Laboratories, Beaumont TX, US |
| Decision | Substantially Equivalent, May 20, 1991 |
| Received | Feb 20, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K910706
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 23, 2018 | Helena Laboratories, Corp. Platelet Aggregation Kit, Cat. No.5369, For use in platelet aggregation studies, Contains: 2X1 mL ADP Reagent containing adenosine diphosphate, 2X 1 mL Collagen Reagent containing collagen (equine ten Open, Classified |
GHR | None listed |
| May 23, 2018 | Helena Laboratories, Corp. Collagen Reagent, Cat. No. 5368, 2 X 1 mL, For use in platelet aggregation studies, Contains: Collagen (equine tendon) For In-Vitro Diagnostic Use, Open, Classified |
GHR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.