K832873 is an FDA 510(k) clearance for the MUMPS COMPLEMENT FIXATION & HEMAGGLU. This device is classified as a Antigen, Cf (including Cf Control), Mumps Virus (Class I - General Controls, product code GRC).
Submitted by Hazleton Dutchland, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 27, 1983, 124 days after receiving the submission on August 25, 1983.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.3380.
| 510(k) Number | K832873 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 25, 1983 |
| Decision Date | December 27, 1983 |
| Days to Decision | 124 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | GRC — Antigen, Cf (including Cf Control), Mumps Virus |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3380 |