K820192 is an FDA 510(k) clearance for the HAEMOPHILUS INFLUENZAE TYPE B ANTISERUM. This device is classified as a Antisera, All Types, H. Influenza (Class II - Special Controls, product code GRP).
Submitted by Hyland Therapeutic Div., Travenol Laboratories (Walker, US). The FDA issued a Cleared decision on March 11, 1982, 45 days after receiving the submission on January 25, 1982.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3300.
| 510(k) Number | K820192 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 25, 1982 |
| Decision Date | March 11, 1982 |
| Days to Decision | 45 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | GRP — Antisera, All Types, H. Influenza |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3300 |