RADIAS NEONATAL T4 ENZYME IMMUNOASSAY— 510(k) K951321

Substantially Equivalent

Bio-Rad

FDA 510(k) clearance K951321 for RADIAS NEONATAL T4 ENZYME IMMUNOASSAY, Substantially Equivalent on 1995-08-24. 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: 1995-03-23
Decision date: 1995-08-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hercules, CA, US

Download summary PDF View on FDA.gov ↗

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