FDA Product Code
FDA Product Code DDQ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.7060
510(k) Clearances — 4 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K972257 | N-ASSAY TIA ANTITHROMBIN III TEST KIT | Crestat Diagnostics, Inc. | 1997-10-20 | Traditional | PDF ↗ |
| K935307 | DADE(R) THROMBIN-ANTITHROMBIN (TAT) COMPLEX ELISA | Baxter Diagnostics, Inc. | 1994-11-22 | Traditional | PDF ↗ |
| K932713 | TRACE TRANSFERRIN REAGENT | Trace Scientific , Ltd. | 1993-09-30 | Traditional | PDF ↗ |
| K780012 | ANTITHROMBIN III RIA | Ria Diagnostics | 1978-01-20 | Traditional | PDF ↗ |
Product code DDQ · Class II · Hematology. Data: openFDA.