K770811 is an FDA 510(k) clearance for the ADENOVIRUS GROUP-FA LABELLED PRESERUM. This device is classified as a Antisera, Fluorescent, Adenovirus 1-33 (Class I - General Controls, product code GNY).
Submitted by Flow Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 20, 1977, 17 days after receiving the submission on May 3, 1977.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.3020.
| 510(k) Number | K770811 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 03, 1977 |
| Decision Date | May 20, 1977 |
| Days to Decision | 17 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | GNY — Antisera, Fluorescent, Adenovirus 1-33 |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3020 |