K772080 is an FDA 510(k) clearance for the RADIAL IMMUNODIFFUSION KIT-ALPH-L-ANTIT. This device is classified as a Alpha-1-antitrypsin, Antigen, Antiserum, Control (Class II - Special Controls, product code DEM).
Submitted by Gelman Instrument Co. (Mchenry, US). The FDA issued a Cleared decision on February 3, 1978, 92 days after receiving the submission on November 3, 1977.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5130.
| 510(k) Number | K772080 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 03, 1977 |
| Decision Date | February 03, 1978 |
| Days to Decision | 92 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | DEM — Alpha-1-antitrypsin, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5130 |