K771243 is an FDA 510(k) clearance for the ANTISERA TO HUMAN FAB FRAGMENT. This device is classified as a Igg (fab Fragment Specific), Antigen, Antiserum, Control (Class I - General Controls, product code DFK).
Submitted by Kent Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 3, 1977, 23 days after receiving the submission on July 11, 1977.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.5520.
| 510(k) Number | K771243 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 11, 1977 |
| Decision Date | August 03, 1977 |
| Days to Decision | 23 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | DFK — Igg (fab Fragment Specific), Antigen, Antiserum, Control |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.5520 |