QUANTIMUNE HFSH RIA— 510(k) K791836

Substantially Equivalent

Bio-Rad

FDA 510(k) clearance K791836 for QUANTIMUNE HFSH RIA, Substantially Equivalent on 1979-10-01. Applicant: Bio-Rad. Device class: 1.

Clearance details

Applicant: Bio-Rad
Product code: Code CGJ
Device class: Class 1
Regulation: 21 CFR 862.1300
Advisory panel: Clinical Chemistry
Date received: 1979-09-14
Decision date: 1979-10-01
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.