K103363 is an FDA 510(k) clearance for the ZEUS ELISA HSV GC-I IGG TEST SYSTEM. This device is classified as 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 FDA review panel. Regulated under 21 CFR 866.3305.
| 510(k) Number | K103363 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| Product Code | MXJ — Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3305 |