Submission Details
| 510(k) Number | K042118 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 06, 2004 |
| Decision Date | April 29, 2005 |
| Days to Decision | 266 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
Cleared
Traditional
ATHENA MULTI-LYTE EBV IGG TEST SYSTEM
Apr 2005
Decision
266d
Days
Class 1
Risk
About This 510(k) Submission
K042118 is an FDA 510(k) clearance for the ATHENA MULTI-LYTE EBV IGG TEST SYSTEM, a Antiserum, Fluorescent, Epstein-barr Virus (Class I — General Controls, product code JRY), submitted by Zeus Scientific, Inc. (Branchburg, US). The FDA issued a Cleared decision on April 29, 2005, 266 days after receiving the submission on August 6, 2004. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3235.
Device Classification
| Product Code | JRY — Antiserum, Fluorescent, Epstein-barr Virus |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 866.3235 |
Manufacturer
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