K021103 is an FDA 510(k) clearance for the MODIFICATION TO ZEUS SCIENTIFIC'S ATHENA MULTI-LYTE ANA TEST SYSTEM. This device is classified as a Antinuclear Antibody, Antigen, Control (Class II - Special Controls, product code LKJ).
Submitted by Zeus Scientific, Inc. (Raritan, US). The FDA issued a Cleared decision on April 24, 2002, 19 days after receiving the submission on April 5, 2002.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5100.
| 510(k) Number | K021103 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 05, 2002 |
| Decision Date | April 24, 2002 |
| Days to Decision | 19 days |
| Submission Type | Special |
| 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 |