DDQ — Antigen, Antiserum, Control, Antithrombin Iii Class II
FDA product code DDQ covers "Antigen, Antiserum, Control, Antithrombin Iii", a Class II medical device regulated under 21 CFR 864.7060. Submissions are reviewed by the Hematology panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DDQ
- Device Class
- Class II
- Regulation Number
- 864.7060
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K972257 | crestat diagnostics | N-ASSAY TIA ANTITHROMBIN III TEST KIT | October 20, 1997 |
| K935307 | baxter diagnostics | DADE(R) THROMBIN-ANTITHROMBIN (TAT) COMPLEX ELISA | November 22, 1994 |
| K932713 | trace scientific | TRACE TRANSFERRIN REAGENT | September 30, 1993 |
| K780012 | ria diagnostics | ANTITHROMBIN III RIA | January 20, 1978 |