JBY · Aggregometer, Platelet, Photo-Optical Scanning
Hematology · 21 CFR 864.6675 · Class 2
Overview
| Product Code | JBY |
|---|---|
| Device Name | Aggregometer, Platelet, Photo-Optical Scanning |
| Regulation | 21 CFR 864.6675 |
| Device Class | Class 2 |
| Review Panel | Hematology |
| 3rd-Party Reviewable | Yes |
Identification
A platelet aggregometer 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 (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K912201 | PACKS-4 (TM) ANALYZER | Helena Laboratories | Aug 16, 1991 | SESE |
| K771198 | LUMI-AGGREGOMETER | Chrono-Log Corp. | Aug 2, 1977 | SESE |
Top Applicants
- Chrono-Log Corp. — 1 clearance
- Helena Laboratories — 1 clearance
