ATHENA MULTI-LYTE TORCH IGG PLUS TEST SYSTEM— 510(k) K093784
Substantially EquivalentZeus Scientific, Inc.
FDA 510(k) clearance K093784 for ATHENA MULTI-LYTE TORCH IGG PLUS TEST SYSTEM, Substantially Equivalent on 2010-07-16. Applicant: Zeus Scientific, Inc.. Device class: 2.
Clearance details
- Applicant
- Zeus Scientific, Inc.
- Product code
- Code OPM
- 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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