Submission Details
| 510(k) Number | K042416 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Special
ATHENA MULTI-LYTE ANA-II TEST SYSTEM
Oct 2004
Decision
31d
Days
Class 2
Risk
About This 510(k) Submission
K042416 is an FDA 510(k) clearance for the ATHENA MULTI-LYTE ANA-II TEST SYSTEM, 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 review panel. Regulated under 21 CFR 866.5100.
Device Classification
| Product Code | LKJ — Antinuclear Antibody, Antigen, Control |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 866.5100 |
Manufacturer
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