Submission Details
| 510(k) Number | K011244 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 23, 2001 |
| Decision Date | December 10, 2001 |
| Days to Decision | 231 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
Cleared
Traditional
ZEUS SCIENTIFIC, INC. ATHENA MULTI-LYTE ANA TEST SYSTEM
Dec 2001
Decision
231d
Days
Class 2
Risk
About This 510(k) Submission
K011244 is an FDA 510(k) clearance for the ZEUS SCIENTIFIC, INC. 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 December 10, 2001, 231 days after receiving the submission on April 23, 2001. 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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