K933267 is an FDA 510(k) clearance for the AUTOANTIBODY PROFILE-6 ELISA TEST SYSTEM. This device is classified as a Antinuclear Antibody (enzyme-labeled), Antigen, Controls (Class II - Special Controls, product code LJM).
Submitted by Zeus Scientific, Inc. (Raritan, US). The FDA issued a Cleared decision on December 15, 1993, 162 days after receiving the submission on July 6, 1993.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5100.
| 510(k) Number | K933267 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 06, 1993 |
| Decision Date | December 15, 1993 |
| Days to Decision | 162 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 |