K914028 is an FDA 510(k) clearance for the RUBELLA IGM ELISA TEST SYSTEM. This device is classified as a Enzyme Linked Immunoabsorbent Assay, Rubella (Class II - Special Controls, product code LFX).
Submitted by Zeus Scientific, Inc. (Raritan, US). The FDA issued a Cleared decision on April 22, 1992, 225 days after receiving the submission on September 10, 1991.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3510.
| 510(k) Number | K914028 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 10, 1991 |
| Decision Date | April 22, 1992 |
| Days to Decision | 225 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
| Product Code | LFX — Enzyme Linked Immunoabsorbent Assay, Rubella |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3510 |