K954700 is an FDA 510(k) clearance for the ENZYME IMMUNOASSAY LUPUS SCREEN TEST KIT. This device is classified as a Antinuclear Antibody, Antigen, Control (Class II - Special Controls, product code LKJ).
Submitted by Helix Diagnostics, Inc. (West Sacramento, US). The FDA issued a Cleared decision on December 15, 1995, 64 days after receiving the submission on October 12, 1995.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5100.
| 510(k) Number | K954700 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 12, 1995 |
| Decision Date | December 15, 1995 |
| Days to Decision | 64 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | LKJ — Antinuclear Antibody, Antigen, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5100 |