Platelet Aggregation Reagent
510(k) K850592
Platelet Aggregation Reagent is a Class II device made by Chrono-Log Corp, cleared under FDA 510(k) K850592 on 13 May 1985, active as of 10 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK850592 | Date13 May 1985 | StatusActive |
Official records
- FDA 510(k) database K850592
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- JBX
- FDA applicant
- Chrono-Log Corp.
- Device class
- Class II
- Regulation
- 21 CFR Part 864.6675
- Advisory committee
- Hematology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K850592
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| CHRONO-PAR 390 | 390 | 00811476010154 | — | On the market |
Similar devices
Other devices filed under FDA product code JBX (Aggregrometer, Platelet).
- Platelet Aggregometer Profiler PAP-8E 106077 by Bio/Data Corporation
- Platelet Aggregometer Profiler PAP8E 106075 by Bio/Data Corporation
- ARACHIDONIC ACID by Helena Laboratories, Corp.
- Buffer, Collagen Reagent and Diluent (JBX) by Diagnostica, Inc.
- PAT PLATELET AGGREGATION TEST by Streck Laboratories, Inc.
- Platelet Aggregation Profiler #PAP-4 by Bio/Data Corp.
- ASSERACHROM B-TG KIT by American Bioproducts Co.
- RISTOCETIN PLATELET AGGREGA-REAGENT TEST by Sigma Chemical Co.