K760889 is an FDA 510(k) clearance for the TEST FOR DETECTION OF ANTIRUBELLA ANTIB. 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 November 16, 1976, 21 days after receiving the submission on October 26, 1976.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.3510.
| 510(k) Number | K760889 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 26, 1976 |
| Decision Date | November 16, 1976 |
| Days to Decision | 21 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | GOL — Antigen, Ha (including Ha Control), Rubella |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3510 |