Submission Details
| 510(k) Number | K033977 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 23, 2003 |
| Decision Date | March 22, 2004 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
Cleared
Traditional
ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE TPO/TG IGG TEST SYSTEM
Mar 2004
Decision
90d
Days
Class 2
Risk
About This 510(k) Submission
K033977 is an FDA 510(k) clearance for the ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE TPO/TG IGG TEST SYSTEM, a System, Test, Thyroid Autoantibody (Class II — Special Controls, product code JZO), submitted by Zeus Scientific, Inc. (Branchburg, US). The FDA issued a Cleared decision on March 22, 2004, 90 days after receiving the submission on December 23, 2003. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5870.
Device Classification
| Product Code | JZO — System, Test, Thyroid Autoantibody |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 866.5870 |
Manufacturer
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