K940588 is an FDA 510(k) clearance for the ENZYME IMMUNOASSAY ANTI-SM/RNP ANTIBODY TEST KIT. This device is classified as a Anti-rnp Antibody, Antigen And Control (Class II - Special Controls, product code LKO).
Submitted by Helix Diagnostics, Inc. (West Sacramento, US). The FDA issued a Cleared decision on April 20, 1994, 71 days after receiving the submission on February 8, 1994.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5100.
| 510(k) Number | K940588 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 08, 1994 |
| Decision Date | April 20, 1994 |
| Days to Decision | 71 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | LKO — Anti-rnp Antibody, Antigen And Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5100 |