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
- 510(k)
- 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 | Nov 2, 1993 |
| K912774 | Helena Laboratories | ARACHIDONIC ACID | Aug 22, 1991 |
| K881829 | Streck Laboratories | PAT PLATELET AGGREGATION TEST | Jul 1, 1988 |
| K862775 | American Bioproducts | ASSERACHROM B-TG KIT | Oct 22, 1986 |
| K851025 | Chrono-Log | AGGRO/LINK COMPUTER INTERFACE | Jun 12, 1985 |
| K850592 | Chrono-Log | PLATELET AGGREGATION REAGENT | May 13, 1985 |
| K832929 | Sigma Chemical | RISTOCETIN PLATELET AGGREGA-REAGENT TEST | Sep 29, 1983 |
| K830749 | Chrono-Log | PLATELET AGGREGOMETER | May 16, 1983 |
| K821005 | Bio/Data | PLATELET AGGREGATION PROFILER #PAP-4 | Jun 1, 1982 |
| K811290 | Bio/Data | ARACHIDONIC ACID | Jul 27, 1981 |
| K781710 | Diagnostica | BUFFER, COLLAGEN REAGENT AND DILUENT | Oct 24, 1978 |
| K760159 | Chrono-Log | AGGREGOMETER, DUAL CHANNEL PLATELET | Jul 20, 1976 |