K823348 is an FDA 510(k) clearance for the H. INFLUENZA B ANTISERA FOR CIE. This device is classified as a Antisera, All Types, H. Influenza (Class II - Special Controls, product code GRP).
Submitted by Diagnostica, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 28, 1982, 49 days after receiving the submission on November 9, 1982.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.3300.
| 510(k) Number | K823348 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 09, 1982 |
| Decision Date | December 28, 1982 |
| Days to Decision | 49 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | GRP — Antisera, All Types, H. Influenza |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3300 |