QUANTIMUNE ESTRIOL RIA— 510(k) K820728

Substantially Equivalent

Bio-Rad

FDA 510(k) clearance K820728 for QUANTIMUNE ESTRIOL RIA, Substantially Equivalent on 1982-04-06. Applicant: Bio-Rad. Device class: 1.

Clearance details

Applicant: Bio-Rad
Product code: Code CGI
Device class: Class 1
Regulation: 21 CFR 862.1265
Advisory panel: Clinical Chemistry
Date received: 1982-03-17
Decision date: 1982-04-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.