Reagent, Platelet Aggregation
FDA product code GHR · Class II (moderate risk) · 21 CFR 864.5700 · Hematology
11510(k) clearances
0PMA approvals
2recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K061991 | Plateletworks Arachidonic Acid, Model Pw-AcaGHR · Traditional | Helena Laboratories | 02/23/2007SE |
| K952252 | Adp Reagent, ModifiedGHR · Traditional | Helena Laboratories | 09/08/1995SE |
| K922800 | Platelet Aggregation ReagentsGHR · Traditional | Chrono-Log Corp. | 08/26/1992SE |
| K910800 | Adp ReagentGHR · Traditional | Helena Laboratories | 05/20/1991SE |
| K910706 | Collagen Reagent Cat. No. 5368GHR · Traditional | Helena Laboratories | 05/20/1991SE |
| K910680 | Epinephrine Reagent, Cat. No. 5367GHR · Traditional | Helena Laboratories | 05/20/1991SE |
| K910286 | Platelet Aggregation ReagentsGHR · Traditional | Medical Diagnostic Technologies, Inc. | 03/19/1991SE |
| K900792 | RistocetinGHR · Traditional | Medical Diagnostic Technologies, Inc. | 03/27/1990SE |
| K832428 | Platelet Aggregation Reagent SetGHR · Traditional | Helena Laboratories | 10/20/1983SE |
| K820422 | Platelet AggregometersGHR · Traditional | Chrono-Log Corp. | 03/16/1982SE |
| K760198 | Kit, Platelet Aggregation Reagent (#390)GHR · Traditional | Chrono-Log Corp. | 07/19/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0537-2020 Class III | Collagen Reagent, Cat. No. 5368, 2 X 1 mL, For use in platelet aggregation studies…Through an investigation, it has been determined that vials of Collagen packaged within the Collagen Reagent… | Helena Laboratories, Corp. | 05/23/2018Open, Classified |
| Z-0536-2020 Class III | Platelet Aggregation Kit, Cat. No.5369, For use in platelet aggregation studies…Through an investigation, it has been determined that vials of Collagen packaged within the Collagen Reagent… | Helena Laboratories, Corp. | 05/23/2018Open, Classified |