JBX
12 FDA 510(k) clearances · Product code
68 daysmedian time to decision
93 days90th percentile
12clearances measured
FDA profile
- Official device name
- Aggregrometer, Platelet
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.6675
- Medical specialty
- Hematology
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| AGGRO/LINK CONTROL SOFTWARE (K932566) | Chrono-Log Corp. | 1993-11-02 |
| ARACHIDONIC ACID (K912774) | Helena Laboratories | 1991-08-22 |
| PAT PLATELET AGGREGATION TEST (K881829) | Streck Laboratories, Inc. | 1988-07-01 |
| ASSERACHROM B-TG KIT (K862775) | American Bioproducts Co. | 1986-10-22 |
| AGGRO/LINK COMPUTER INTERFACE (K851025) | Chrono-Log Corp. | 1985-06-12 |
| PLATELET AGGREGATION REAGENT (K850592) | Chrono-Log Corp. | 1985-05-13 |
| RISTOCETIN PLATELET AGGREGA-REAGENT TEST (K832929) | Sigma Chemical Co. | 1983-09-29 |
| PLATELET AGGREGOMETER (K830749) | Chrono-Log Corp. | 1983-05-16 |
| PLATELET AGGREGATION PROFILER #PAP-4 (K821005) | Bio/Data Corp. | 1982-06-01 |
| ARACHIDONIC ACID (K811290) | Bio/Data Corp. | 1981-07-27 |
| BUFFER, COLLAGEN REAGENT AND DILUENT (K781710) | Diagnostica, Inc. | 1978-10-24 |
| AGGREGOMETER, DUAL CHANNEL PLATELET (K760159) | Chrono-Log Corp. | 1976-07-20 |
Track JBX automatically
Every clearance here is in the API, with alerts when new ones post.