GHR — Reagent, Platelet Aggregation Class II
FDA Device Classification
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 |
| K910800 | helena laboratories | ADP REAGENT | May 20, 1991 |
| K910680 | helena laboratories | EPINEPHRINE REAGENT, CAT. NO. 5367 | May 20, 1991 |
| K910706 | helena laboratories | COLLAGEN REAGENT CAT. NO. 5368 | 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 |