K953826 is an FDA 510(k) clearance for the ENZYME LINKED UMMINOABSORBENT ASSAY, RUBELLA. This device is classified as a Antisera, Cf, Rubella (Class II - Special Controls, product code GOM).
Submitted by Pyramid Biological Corp. (Van Nuys, US). The FDA issued a Cleared decision on December 14, 1995, 121 days after receiving the submission on August 15, 1995.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3510.
| 510(k) Number | K953826 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 15, 1995 |
| Decision Date | December 14, 1995 |
| Days to Decision | 121 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
| Product Code | GOM — Antisera, Cf, Rubella |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3510 |