K802937 is an FDA 510(k) clearance for the RUBELLA VIRUS ANTIGENS & CONTROLS. This device is classified as a Antigen, Cf (including Cf Control), Rubella (Class II - Special Controls, product code GON).
Submitted by Orion Diagnostica, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 31, 1980, 42 days after receiving the submission on November 19, 1980.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3510.
| 510(k) Number | K802937 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 19, 1980 |
| Decision Date | December 31, 1980 |
| Days to Decision | 42 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | GON — Antigen, Cf (including Cf Control), Rubella |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3510 |