K800797 is an FDA 510(k) clearance for the MACRO-VUE RUBELLA CARD TEST. This device is classified as a Antigen, Ha (including Ha Control), Rubella (Class II - Special Controls, product code GOL).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on June 20, 1980, 72 days after receiving the submission on April 9, 1980.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3510.
| 510(k) Number | K800797 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 09, 1980 |
| Decision Date | June 20, 1980 |
| Days to Decision | 72 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 |