Submission Details
| 510(k) Number | K103363 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 17, 2010 |
| Decision Date | April 26, 2011 |
| Days to Decision | 160 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
Cleared
Traditional
ZEUS ELISA HSV GC-I IGG TEST SYSTEM
Apr 2011
Decision
160d
Days
Class 2
Risk
About This 510(k) Submission
K103363 is an FDA 510(k) clearance for the ZEUS ELISA HSV GC-I IGG TEST SYSTEM, a Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 (Class II — Special Controls, product code MXJ), submitted by Zeus Scientific, Inc. (Branchburg, US). The FDA issued a Cleared decision on April 26, 2011, 160 days after receiving the submission on November 17, 2010. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3305.
Device Classification
| Product Code | MXJ — Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 866.3305 |
Manufacturer
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