K771669 is an FDA 510(k) clearance for the DIAG. KIT FOR TOTAL ANTITHROMBIN III. This device is classified as a Antithrombin Iii Quantitation (Class II - Special Controls, product code JBQ).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on November 9, 1977, 69 days after receiving the submission on September 1, 1977.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7060.
| 510(k) Number | K771669 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 01, 1977 |
| Decision Date | November 09, 1977 |
| Days to Decision | 69 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | JBQ — Antithrombin Iii Quantitation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7060 |