GHR — Reagent, Platelet Aggregation Class II
FDA product code GHR covers "Reagent, Platelet Aggregation", a Class II medical device regulated under 21 CFR 864.5700. Submissions are reviewed by the Hematology panel. At least 11 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GHR
- Device Class
- Class II
- Regulation Number
- 864.5700
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K061991 | helena laboratories | PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACA | February 23, 2007 |
| K952252 | helena laboratories | ADP REAGENT, MODIFIED | September 8, 1995 |
| K922800 | chrono-log | PLATELET AGGREGATION REAGENTS | August 26, 1992 |
| K910706 | helena laboratories | COLLAGEN REAGENT CAT. NO. 5368 | May 20, 1991 |
| K910680 | helena laboratories | EPINEPHRINE REAGENT, CAT. NO. 5367 | May 20, 1991 |
| K910800 | helena laboratories | ADP REAGENT | May 20, 1991 |
| K910286 | medical diagnostic technologies | PLATELET AGGREGATION REAGENTS | March 19, 1991 |
| K900792 | medical diagnostic technologies | RISTOCETIN | March 27, 1990 |
| K832428 | helena laboratories | PLATELET AGGREGATION REAGENT SET | October 20, 1983 |
| K820422 | chrono-log | PLATELET AGGREGOMETERS | March 16, 1982 |
| K760198 | chrono-log | KIT, PLATELET AGGREGATION REAGENT (#390) | July 19, 1976 |