VARIANT EXPRESS GLYCOHEMOGLOBIN PROGRAM— 510(k) K972609

Name: FDA 510(k) clearance K972609
Creator: U.S. Food and Drug Administration
Published: 1997-08-06

Substantially Equivalent

Bio-Rad

FDA 510(k) clearance K972609 for VARIANT EXPRESS GLYCOHEMOGLOBIN PROGRAM, Substantially Equivalent on 1997-08-06. Applicant: Bio-Rad. Device class: 2.

Clearance details

Applicant: Bio-Rad
Product code: Code LCQ
Device class: Class 2
Regulation: 21 CFR 862.3450
Advisory panel: Clinical Toxicology
Date received: 1997-07-11
Decision date: 1997-08-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hercules, CA, US

Download summary PDF View on FDA.gov ↗

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