K790708 is an FDA 510(k) clearance for the ANTISERUM TO HUMAN IG G FC FRAGMENTS. This device is classified as a Igg (fc Fragment Specific), Antigen, Antiserum, Control (Class I - General Controls, product code DAS).
Submitted by Kent Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 22, 1979, 132 days after receiving the submission on April 12, 1979.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5530.
| 510(k) Number | K790708 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 12, 1979 |
| Decision Date | August 22, 1979 |
| Days to Decision | 132 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | DAS — Igg (fc Fragment Specific), Antigen, Antiserum, Control |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.5530 |