HSV-1 AND/OR -2 IGM ELISA TEST SYSTEM— 510(k) K983656
Substantially EquivalentZeus Scientific, Inc.
FDA 510(k) clearance K983656 for HSV-1 AND/OR -2 IGM ELISA TEST SYSTEM, Substantially Equivalent on 1999-03-18. Applicant: Zeus Scientific, Inc.. Device class: 2.
Clearance details
- Applicant
- Zeus Scientific, Inc.
- Product code
- Code LGC
- Device class
- Class 2
- Regulation
- 21 CFR 866.3305
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Branchburg, NJ, US
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