K810835 is an FDA 510(k) clearance for the RUBAZYME - M. This device is classified as a Antisera, Hai (including Hai Control), Rubella (Class II - Special Controls, product code GOK).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on May 5, 1981, 41 days after receiving the submission on March 25, 1981.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.3510.
| 510(k) Number | K810835 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 25, 1981 |
| Decision Date | May 05, 1981 |
| Days to Decision | 41 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | GOK — Antisera, Hai (including Hai Control), Rubella |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3510 |