Submission Details
| 510(k) Number | K051484 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 06, 2005 |
| Decision Date | December 05, 2005 |
| Days to Decision | 182 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
Cleared
Traditional
ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MMRV IGG TEST SYSTEM.
Dec 2005
Decision
182d
Days
Class 2
Risk
About This 510(k) Submission
K051484 is an FDA 510(k) clearance for the ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MMRV IGG TEST SYSTEM., a Enzyme Linked Immunoabsorbent Assay, Varicella-zoster (Class II — Special Controls, product code LFY), submitted by Zeus Scientific, Inc. (Branchburg, US). The FDA issued a Cleared decision on December 5, 2005, 182 days after receiving the submission on June 6, 2005. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3900.
Device Classification
| Product Code | LFY — Enzyme Linked Immunoabsorbent Assay, Varicella-zoster |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 866.3900 |
Manufacturer
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