QUANTIGEN T & B CELL ASSAY— 510(k) K831053

Substantially Equivalent

Bio-Rad

FDA 510(k) clearance K831053 for QUANTIGEN T & B CELL ASSAY, Substantially Equivalent on 1983-08-08. Applicant: Bio-Rad. Device class: 2.

Clearance details

Applicant: Bio-Rad
Product code: Code LIZ
Device class: Class 2
Regulation: 21 CFR 864.5220
Advisory panel: Hematology
Date received: 1983-04-01
Decision date: 1983-08-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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