QUANTA PHASE VITAMIN B-12/FOLATE RAD— 510(k) K811177

Substantially Equivalent

Bio-Rad

FDA 510(k) clearance K811177 for QUANTA PHASE VITAMIN B-12/FOLATE RAD, Substantially Equivalent on 1981-05-15. Applicant: Bio-Rad. Device class: 2.

Clearance details

Applicant: Bio-Rad
Product code: Code CGN
Device class: Class 2
Regulation: 21 CFR 862.1295
Advisory panel: Clinical Chemistry
Date received: 1981-04-28
Decision date: 1981-05-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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