K913667 is an FDA 510(k) clearance for the ANTITHROMBIN III IMMUNOLOGICAL NL TEST KIT. This device is classified as a Antithrombin Iii Quantitation (Class II - Special Controls, product code JBQ).
Submitted by The Binding Site, Ltd. (Los Angeles, US). The FDA issued a Cleared decision on January 3, 1992, 137 days after receiving the submission on August 19, 1991.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7060.
| 510(k) Number | K913667 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 19, 1991 |
| Decision Date | January 03, 1992 |
| Days to Decision | 137 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Statement |
| Product Code | JBQ — Antithrombin Iii Quantitation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7060 |