Liquichek Tumor Marker Control-Level 1 +3 more— 510(k) K163015
Substantially EquivalentBio-Rad Laboratories
FDA 510(k) clearance K163015 for Liquichek Tumor Marker Control-Level 1 +3 more, Substantially Equivalent on 2017-01-10. Applicant: Bio-Rad Laboratories. Device class: 1.
Clearance details
- Device name as filed
- Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPak
- 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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