Submission Details
| 510(k) Number | K021103 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Special
MODIFICATION TO ZEUS SCIENTIFIC'S ATHENA MULTI-LYTE ANA TEST SYSTEM
Apr 2002
Decision
19d
Days
Class 2
Risk
About This 510(k) Submission
K021103 is an FDA 510(k) clearance for the MODIFICATION TO ZEUS SCIENTIFIC'S ATHENA MULTI-LYTE ANA 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 April 24, 2002, 19 days after receiving the submission on April 5, 2002. 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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