JBX · Aggregrometer, Platelet
Hematology · 21 CFR 864.6675 · Class 2
Overview
| Product Code | JBX |
|---|---|
| Device Name | Aggregrometer, Platelet |
| 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 (12 of 12)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K932566 | AGGRO/LINK CONTROL SOFTWARE | Chrono-Log Corp. | Nov 2, 1993 | SESE |
| K912774 | ARACHIDONIC ACID | Helena Laboratories | Aug 22, 1991 | SESE |
| K881829 | PAT PLATELET AGGREGATION TEST | Streck Laboratories, Inc. | Jul 1, 1988 | SESE |
| K862775 | ASSERACHROM B-TG KIT | American Bioproducts Co. | Oct 22, 1986 | SESE |
| K851025 | AGGRO/LINK COMPUTER INTERFACE | Chrono-Log Corp. | Jun 12, 1985 | SESE |
| K850592 | PLATELET AGGREGATION REAGENT | Chrono-Log Corp. | May 13, 1985 | SESE |
| K832929 | RISTOCETIN PLATELET AGGREGA-REAGENT TEST | Sigma Chemical Co. | Sep 29, 1983 | SESE |
| K830749 | PLATELET AGGREGOMETER | Chrono-Log Corp. | May 16, 1983 | SESE |
| K821005 | PLATELET AGGREGATION PROFILER #PAP-4 | Bio/Data Corp. | Jun 1, 1982 | SESE |
| K811290 | ARACHIDONIC ACID | Bio/Data Corp. | Jul 27, 1981 | SESE |
| K781710 | BUFFER, COLLAGEN REAGENT AND DILUENT | Diagnostica, Inc. | Oct 24, 1978 | SESE |
| K760159 | AGGREGOMETER, DUAL CHANNEL PLATELET | Chrono-Log Corp. | Jul 20, 1976 | SESE |
Top Applicants
- Chrono-Log Corp. — 5 clearances
- Bio/Data Corp. — 2 clearances
- American Bioproducts Co. — 1 clearance
- Diagnostica, Inc. — 1 clearance
- Helena Laboratories — 1 clearance
