JBX — Aggregrometer, Platelet Class II
FDA product code JBX covers "Aggregrometer, Platelet", a Class II medical device regulated under 21 CFR 864.6675. Submissions are reviewed by the Hematology panel. At least 12 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- JBX
- Device Class
- Class II
- Regulation Number
- 864.6675
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K932566 | chrono-log | AGGRO/LINK CONTROL SOFTWARE | November 2, 1993 |
| K912774 | helena laboratories | ARACHIDONIC ACID | August 22, 1991 |
| K881829 | streck laboratories | PAT PLATELET AGGREGATION TEST | July 1, 1988 |
| K862775 | american bioproducts | ASSERACHROM B-TG KIT | October 22, 1986 |
| K851025 | chrono-log | AGGRO/LINK COMPUTER INTERFACE | June 12, 1985 |
| K850592 | chrono-log | PLATELET AGGREGATION REAGENT | May 13, 1985 |
| K832929 | sigma chemical | RISTOCETIN PLATELET AGGREGA-REAGENT TEST | September 29, 1983 |
| K830749 | chrono-log | PLATELET AGGREGOMETER | May 16, 1983 |
| K821005 | bio/data | PLATELET AGGREGATION PROFILER #PAP-4 | June 1, 1982 |
| K811290 | bio/data | ARACHIDONIC ACID | July 27, 1981 |
| K781710 | diagnostica | BUFFER, COLLAGEN REAGENT AND DILUENT | October 24, 1978 |
| K760159 | chrono-log | AGGREGOMETER, DUAL CHANNEL PLATELET | July 20, 1976 |