K820499 is an FDA 510(k) clearance for the FITC ANTI-RABIES MONOCLONAL GLOBULIN. This device is classified as a Antiserum, Fluorescent, Rabies Virus (Class II - Special Controls, product code GOI).
Submitted by Centocor, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 16, 1982, 52 days after receiving the submission on February 23, 1982.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3460.
| 510(k) Number | K820499 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 23, 1982 |
| Decision Date | April 16, 1982 |
| Days to Decision | 52 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | GOI — Antiserum, Fluorescent, Rabies Virus |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3460 |