K770670 is an FDA 510(k) clearance for the FLOR. CONJUG. 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 April 28, 1977, 20 days after receiving the submission on April 8, 1977.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5520.
| 510(k) Number | K770670 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 08, 1977 |
| Decision Date | April 28, 1977 |
| Days to Decision | 20 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | DFK — Igg (fab Fragment Specific), Antigen, Antiserum, Control |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.5520 |