LIQUICHEK CARDIAC TROPONINS CONTROL, LEVELS 1,2 AND 3, TRILEVEL/MINIPAK— 510(k) K140916
Substantially EquivalentBio-Rad Laboratories
FDA 510(k) clearance K140916 for LIQUICHEK CARDIAC TROPONINS CONTROL, LEVELS 1,2 AND 3, TRILEVEL/MINIPAK, Substantially Equivalent on 2014-05-06. Applicant: Bio-Rad Laboratories. Device class: 1.
Clearance details
- Applicant
- Bio-Rad Laboratories
- 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
- Irvine, CA, US
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