FDA Product Code
FDA Product Code JBR — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.7525
510(k) Clearances — 3 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K925452 | DADE HEPZYME | Baxter Diagnostics, Inc. | 1993-01-11 | Traditional | PDF ↗ |
| K874373 | PT PRO-CLOT | Probe-Tek, Inc. | 1988-01-05 | Traditional | PDF ↗ |
| K770722 | THROMBO SCREEN QUANTITATIVE HEPARIN ASSA | Bay Area Hema. Onco. Clinic. & Res. L | 1977-07-11 | Traditional | PDF ↗ |
Product code JBR · Class II · Hematology. Data: openFDA.