K042416 is an FDA 510(k) clearance for the ATHENA MULTI-LYTE ANA-II 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 October 8, 2004, 31 days after receiving the submission on September 7, 2004.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5100.
| 510(k) Number | K042416 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 07, 2004 |
| Decision Date | October 08, 2004 |
| Days to Decision | 31 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 |