FDA Product Code
FDA Product Code GHR — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.5700
510(k) Clearances — 11 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K061991 | PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACA | Helena Laboratories | 2007-02-23 | Traditional | PDF ↗ |
| K952252 | ADP REAGENT, MODIFIED | Helena Laboratories | 1995-09-08 | Traditional | PDF ↗ |
| K922800 | PLATELET AGGREGATION REAGENTS | Chrono-Log Corp. | 1992-08-26 | Traditional | PDF ↗ |
| K910800 | ADP REAGENT | Helena Laboratories | 1991-05-20 | Traditional | PDF ↗ |
| K910680 | EPINEPHRINE REAGENT, CAT. NO. 5367 | Helena Laboratories | 1991-05-20 | Traditional | PDF ↗ |
| K910706 | COLLAGEN REAGENT CAT. NO. 5368 | Helena Laboratories | 1991-05-20 | Traditional | PDF ↗ |
| K910286 | PLATELET AGGREGATION REAGENTS | Medical Diagnostic Technologies, Inc. | 1991-03-19 | Traditional | PDF ↗ |
| K900792 | RISTOCETIN | Medical Diagnostic Technologies, Inc. | 1990-03-27 | Traditional | PDF ↗ |
| K832428 | PLATELET AGGREGATION REAGENT SET | Helena Laboratories | 1983-10-20 | Traditional | PDF ↗ |
| K820422 | PLATELET AGGREGOMETERS | Chrono-Log Corp. | 1982-03-16 | Traditional | PDF ↗ |
| K760198 | KIT, PLATELET AGGREGATION REAGENT (#390) | Chrono-Log Corp. | 1976-07-19 | Traditional | PDF ↗ |
Product code GHR · Class II · Hematology. Data: openFDA.