GHR · Reagent, Platelet Aggregation
Hematology · 21 CFR 864.5700 · Class 2
Overview
| Product Code | GHR |
|---|---|
| Device Name | Reagent, Platelet Aggregation |
| Regulation | 21 CFR 864.5700 |
| Device Class | Class 2 |
| Review Panel | Hematology |
| 3rd-Party Reviewable | Yes |
Identification
An automated platelet aggregation system is a device used to determine changes in platelet shape and platelet aggregation following the addition of an aggregating reagent to a platelet-rich plasma.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (11 of 11)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K061991 | PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACA | Helena Laboratories | Feb 23, 2007 | SESE |
| K952252 | ADP REAGENT, MODIFIED | Helena Laboratories | Sep 8, 1995 | SESE |
| K922800 | PLATELET AGGREGATION REAGENTS | Chrono-Log Corp. | Aug 26, 1992 | SESE |
| K910800 | ADP REAGENT | Helena Laboratories | May 20, 1991 | SESE |
| K910706 | COLLAGEN REAGENT CAT. NO. 5368 | Helena Laboratories | May 20, 1991 | SESE |
| K910680 | EPINEPHRINE REAGENT, CAT. NO. 5367 | Helena Laboratories | May 20, 1991 | SESE |
| K910286 | PLATELET AGGREGATION REAGENTS | Medical Diagnostic Technologies, Inc. | Mar 19, 1991 | SESE |
| K900792 | RISTOCETIN | Medical Diagnostic Technologies, Inc. | Mar 27, 1990 | SESE |
| K832428 | PLATELET AGGREGATION REAGENT SET | Helena Laboratories | Oct 20, 1983 | SESE |
| K820422 | PLATELET AGGREGOMETERS | Chrono-Log Corp. | Mar 16, 1982 | SESE |
| K760198 | KIT, PLATELET AGGREGATION REAGENT (#390) | Chrono-Log Corp. | Jul 19, 1976 | SESE |
Top Applicants
- Helena Laboratories — 6 clearances
- Chrono-Log Corp. — 3 clearances
- Medical Diagnostic Technologies, Inc. — 2 clearances
