Submission Details
| 510(k) Number | K103603 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 08, 2010 |
| Decision Date | May 20, 2011 |
| Days to Decision | 163 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
Cleared
Traditional
ZEUS ELISA HSV GG-2 IGG TEST SYSTEM
May 2011
Decision
163d
Days
Class 2
Risk
About This 510(k) Submission
K103603 is an FDA 510(k) clearance for the ZEUS ELISA HSV GG-2 IGG TEST SYSTEM, a Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 (Class II — Special Controls, product code MYF), submitted by Zeus Scientific, Inc. (Branchburg, US). The FDA issued a Cleared decision on May 20, 2011, 163 days after receiving the submission on December 8, 2010. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3305.
Device Classification
| Product Code | MYF — Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 866.3305 |
Manufacturer
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