K813493 is an FDA 510(k) clearance for the ENZYGNOST TM RUBELLA IGM. This device is classified as a Enzyme Linked Immunoabsorbent Assay, Rubella (Class II - Special Controls, product code LFX).
Submitted by Calbiochem-Behring Corp. (Walker, US). The FDA issued a Cleared decision on March 4, 1982, 80 days after receiving the submission on December 14, 1981.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.3510.
| 510(k) Number | K813493 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 14, 1981 |
| Decision Date | March 04, 1982 |
| Days to Decision | 80 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | LFX — Enzyme Linked Immunoabsorbent Assay, Rubella |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3510 |