Panels › Hematology › Product code GHR · Class 2
Reagent, Platelet Aggregation
Regulation 864.5700
0510(k)s in 12 months (11 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in GHR
| Company | 510(k)s | Recalls |
|---|---|---|
| Helena Laboratories | 6 | 2 |
| Chrono-Log Corp. | 3 | 0 |
| Medical Diagnostic Technologies, Inc. | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | K910706 |
| 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 | K910706 |
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