K944171 is an FDA 510(k) clearance for the VARELISA CENTROMERE ANTIBODIES. This device is classified as a Antinuclear Antibody (enzyme-labeled), Antigen, Controls (Class II - Special Controls, product code LJM).
Submitted by Elias U.S.A., Inc. (Osceola, US). The FDA issued a Cleared decision on December 22, 1994, 118 days after receiving the submission on August 26, 1994.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5100.
| 510(k) Number | K944171 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 26, 1994 |
| Decision Date | December 22, 1994 |
| Days to Decision | 118 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 |