K931059 is an FDA 510(k) clearance for the IMX RUBELLA IGM ANTIBODY ASSAY. This device is classified as a Enzyme Linked Immunoabsorbent Assay, Rubella (Class II - Special Controls, product code LFX).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on December 19, 1994, 658 days after receiving the submission on March 1, 1993.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3510.
| 510(k) Number | K931059 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 01, 1993 |
| Decision Date | December 19, 1994 |
| Days to Decision | 658 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | LFX — Enzyme Linked Immunoabsorbent Assay, Rubella |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3510 |