K913666 is an FDA 510(k) clearance for the ALPHA-1-ANTITRYPSIN IMMUNOLOGICAL NL TEST KIT. This device is classified as a Alpha-1-antitrypsin, Antigen, Antiserum, Control (Class II - Special Controls, product code DEM).
Submitted by The Binding Site, Ltd. (Los Angeles, US). The FDA issued a Cleared decision on December 9, 1991, 112 days after receiving the submission on August 19, 1991.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5130.
| 510(k) Number | K913666 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 19, 1991 |
| Decision Date | December 09, 1991 |
| Days to Decision | 112 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | DEM — Alpha-1-antitrypsin, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5130 |