RADIAS TOTAL T4 ENZYME IMMUNOASSAY— 510(k) K946163

Substantially Equivalent

Bio-Rad

FDA 510(k) clearance K946163 for RADIAS TOTAL T4 ENZYME IMMUNOASSAY, Substantially Equivalent on 1995-02-22. Applicant: Bio-Rad. Device class: 2.

Clearance details

Applicant: Bio-Rad
Product code: Code KLI
Device class: Class 2
Regulation: 21 CFR 862.1700
Advisory panel: Clinical Chemistry
Date received: 1994-12-19
Decision date: 1995-02-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hercules, CA, US

Download summary PDF View on FDA.gov ↗

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