LIQUICHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL TILEVEL (1,2 AND 3)— 510(k) K121143

Name: FDA 510(k) clearance K121143
Creator: U.S. Food and Drug Administration
Published: 2012-05-18

Substantially Equivalent

Bio-Rad Laboratories

FDA 510(k) clearance K121143 for LIQUICHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL TILEVEL (1,2 AND 3), Substantially Equivalent on 2012-05-18. Applicant: Bio-Rad Laboratories. Device class: 1.

Clearance details

Applicant: Bio-Rad Laboratories
Product code: Code DIF
Device class: Class 1
Regulation: 21 CFR 862.3280
Advisory panel: Clinical Toxicology
Date received: 2012-04-16
Decision date: 2012-05-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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