Submission Details
| 510(k) Number | K072178 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 06, 2007 |
| Decision Date | May 30, 2008 |
| Days to Decision | 298 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
Cleared
Traditional
ATHENA MULTI-LYTE HSV 1 & 2 IGG TEST SYSTEM
May 2008
Decision
298d
Days
Class 2
Risk
About This 510(k) Submission
K072178 is an FDA 510(k) clearance for the ATHENA MULTI-LYTE HSV 1 & 2 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 May 30, 2008, 298 days after receiving the submission on August 6, 2007. 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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