Submission Details
| 510(k) Number | K063186 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 20, 2006 |
| Decision Date | March 21, 2007 |
| Days to Decision | 152 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
Cleared
Traditional
ATHENA MULTI-LYTE RUBELLA IGG TEST SYSTEM
Mar 2007
Decision
152d
Days
Class 2
Risk
About This 510(k) Submission
K063186 is an FDA 510(k) clearance for the ATHENA MULTI-LYTE RUBELLA IGG TEST SYSTEM, a Enzyme Linked Immunoabsorbent Assay, Rubella (Class II — Special Controls, product code LFX), submitted by Zeus Scientific, Inc. (Raritan, US). The FDA issued a Cleared decision on March 21, 2007, 152 days after receiving the submission on October 20, 2006. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3510.
Device Classification
| Product Code | LFX — Enzyme Linked Immunoabsorbent Assay, Rubella |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 866.3510 |
Manufacturer
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