GHR
11 FDA 510(k) clearances · Product code
84 daysmedian time to decision
116 days90th percentile
11clearances measured
FDA profile
- Official device name
- Reagent, Platelet Aggregation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5700
- Medical specialty
- Hematology
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACA (K061991) | Helena Laboratories | 2007-02-23 |
| ADP REAGENT, MODIFIED (K952252) | Helena Laboratories | 1995-09-08 |
| PLATELET AGGREGATION REAGENTS (K922800) | Chrono-Log Corp. | 1992-08-26 |
| ADP REAGENT (K910800) | Helena Laboratories | 1991-05-20 |
| COLLAGEN REAGENT CAT. NO. 5368 (K910706) | Helena Laboratories | 1991-05-20 |
| EPINEPHRINE REAGENT, CAT. NO. 5367 (K910680) | Helena Laboratories | 1991-05-20 |
| PLATELET AGGREGATION REAGENTS (K910286) | Medical Diagnostic Technologies, Inc. | 1991-03-19 |
| RISTOCETIN (K900792) | Medical Diagnostic Technologies, Inc. | 1990-03-27 |
| PLATELET AGGREGATION REAGENT SET (K832428) | Helena Laboratories | 1983-10-20 |
| PLATELET AGGREGOMETERS (K820422) | Chrono-Log Corp. | 1982-03-16 |
| KIT, PLATELET AGGREGATION REAGENT (#390) (K760198) | Chrono-Log Corp. | 1976-07-19 |
Track GHR automatically
Every clearance here is in the API, with alerts when new ones post.