FDA Product Code
FDA Product Code JBX — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.6675
510(k) Clearances — 12 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K932566 | AGGRO/LINK CONTROL SOFTWARE | Chrono-Log Corp. | 1993-11-02 | Traditional | PDF ↗ |
| K912774 | ARACHIDONIC ACID | Helena Laboratories | 1991-08-22 | Traditional | PDF ↗ |
| K881829 | PAT PLATELET AGGREGATION TEST | Streck Laboratories, Inc. | 1988-07-01 | Traditional | PDF ↗ |
| K862775 | ASSERACHROM B-TG KIT | American Bioproducts Co. | 1986-10-22 | Traditional | PDF ↗ |
| K851025 | AGGRO/LINK COMPUTER INTERFACE | Chrono-Log Corp. | 1985-06-12 | Traditional | PDF ↗ |
| K850592 | PLATELET AGGREGATION REAGENT | Chrono-Log Corp. | 1985-05-13 | Traditional | PDF ↗ |
| K832929 | RISTOCETIN PLATELET AGGREGA-REAGENT TEST | Sigma Chemical Co. | 1983-09-29 | Traditional | PDF ↗ |
| K830749 | PLATELET AGGREGOMETER | Chrono-Log Corp. | 1983-05-16 | Traditional | PDF ↗ |
| K821005 | PLATELET AGGREGATION PROFILER #PAP-4 | Bio/Data Corp. | 1982-06-01 | Traditional | PDF ↗ |
| K811290 | ARACHIDONIC ACID | Bio/Data Corp. | 1981-07-27 | Traditional | PDF ↗ |
| K781710 | BUFFER, COLLAGEN REAGENT AND DILUENT | Diagnostica, Inc. | 1978-10-24 | Traditional | PDF ↗ |
| K760159 | AGGREGOMETER, DUAL CHANNEL PLATELET | Chrono-Log Corp. | 1976-07-20 | Traditional | PDF ↗ |
Product code JBX · Class II · Hematology. Data: openFDA.