THERMO SCIENTIFIC MAS OMNI-CARDIO— 510(k) K122291
Substantially EquivalentMicrogenics Corporation
FDA 510(k) clearance K122291 for THERMO SCIENTIFIC MAS OMNI-CARDIO, Substantially Equivalent on 2012-08-31. Applicant: Microgenics Corporation. Device class: 1.
Clearance details
- Applicant
- Microgenics Corporation
- Product code
- Code JJY
- Device class
- Class 1
- Regulation
- 21 CFR 862.1660
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fremont Blvd., CA, US
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