K951850 is an FDA 510(k) clearance for the ENZYME IMMUNOASSAY ANTI-JO-1 ANTIBODY TEST KIT. This device is classified as a Antinuclear Antibody (enzyme-labeled), Antigen, Controls (Class II - Special Controls, product code LJM).
Submitted by Helix Diagnostics, Inc. (West Sacramento, US). The FDA issued a Cleared decision on July 18, 1995, 88 days after receiving the submission on April 21, 1995.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5100.
| 510(k) Number | K951850 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 21, 1995 |
| Decision Date | July 18, 1995 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | LJM — Antinuclear Antibody (enzyme-labeled), Antigen, Controls |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5100 |