Submission Details
| 510(k) Number | K070317 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 02, 2007 |
| Decision Date | July 05, 2007 |
| Days to Decision | 153 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
Cleared
Traditional
ZEUS SCIENTIFIC, INC VZV IGM ELISA TEST SYSTEM
Jul 2007
Decision
153d
Days
Class 2
Risk
About This 510(k) Submission
K070317 is an FDA 510(k) clearance for the ZEUS SCIENTIFIC, INC VZV IGM ELISA 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 July 5, 2007, 153 days after receiving the submission on February 2, 2007. 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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