K811637 is an FDA 510(k) clearance for the RUBELLA LATEX CARD TEST. This device is classified as a Free Radical Assay, Morphine (Class II - Special Controls, product code DOK).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on August 13, 1981, 64 days after receiving the submission on June 10, 1981.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 862.3640.
| 510(k) Number | K811637 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 10, 1981 |
| Decision Date | August 13, 1981 |
| Days to Decision | 64 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | DOK — Free Radical Assay, Morphine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3640 |