LYPHOCHEK GLYCATED HEMOGLOBIN/WHOLE BLOOD/LEV.I&II— 510(k) K862186

Name: FDA 510(k) clearance K862186
Creator: U.S. Food and Drug Administration
Published: 1986-07-01

Substantially Equivalent

Bio-Rad

FDA 510(k) clearance K862186 for LYPHOCHEK GLYCATED HEMOGLOBIN/WHOLE BLOOD/LEV.I&II, Substantially Equivalent on 1986-07-01. Applicant: Bio-Rad. Device class: 2.

Clearance details

Applicant: Bio-Rad
Product code: Code JPK
Device class: Class 2
Regulation: 21 CFR 864.8625
Advisory panel: Hematology
Date received: 1986-06-09
Decision date: 1986-07-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Richmond, CA, US

Download summary PDF View on FDA.gov ↗

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