ATHENA MULTI-LYTE RUBELLA IGG TEST SYSTEM— 510(k) K063186
Substantially EquivalentZeus Scientific, Inc.
FDA 510(k) clearance K063186 for ATHENA MULTI-LYTE RUBELLA IGG TEST SYSTEM, Substantially Equivalent on 2007-03-21. Applicant: Zeus Scientific, Inc.. Device class: 2.
Clearance details
- Applicant
- Zeus Scientific, Inc.
- Product code
- Code LFX
- Device class
- Class 2
- Regulation
- 21 CFR 866.3510
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Raritan, NJ, US
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