K790976 is an FDA 510(k) clearance for the RUBAZYME. This device is classified as a Antigen, Ha (including Ha Control), Rubella (Class II - Special Controls, product code GOL).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on August 16, 1979, 85 days after receiving the submission on May 23, 1979.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3510.
| 510(k) Number | K790976 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 23, 1979 |
| Decision Date | August 16, 1979 |
| Days to Decision | 85 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | GOL — Antigen, Ha (including Ha Control), Rubella |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3510 |