Platelet Aggregometer
510(k) K830749
Platelet Aggregometer is a Class II device made by Chrono-Log Corp, cleared under FDA 510(k) K830749 on 16 May 1983, active as of 9 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 | NumberK830749 | Date16 May 1983 | StatusActive |
Official records
- FDA 510(k) database K830749
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- Withdrawn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 K830749
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-log 590 | 590-2D / 590 | 00811476010369 | — | On the market |
| Chrono-log 590 | 590-4D / 590 | 00811476010963 | — | On the market |
| Chrono-log 590 | 590-X / 590 | 00811476010376 | — | On the market |
Similar devices
Other devices filed under FDA product code JBX (Aggregrometer, Platelet).
- ARACHIDONIC ACID by Bio/Data 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.
- Platelet Aggregometer Profiler PAP-8E 106077 by Bio/Data Corporation
- Platelet Aggregometer Profiler PAP8E 106075 by Bio/Data Corporation