LYPHOCHEK HEMOGLOBIN ALC LINEARITY SET— 510(k) K003030

Substantially Equivalent

Bio-Rad

FDA 510(k) clearance K003030 for LYPHOCHEK HEMOGLOBIN ALC LINEARITY SET, Substantially Equivalent on 2000-11-29. Applicant: Bio-Rad. Device class: 2.

Clearance details

Applicant: Bio-Rad
Product code: Code GGM
Device class: Class 2
Regulation: 21 CFR 864.8625
Advisory panel: Hematology
Date received: 2000-09-28
Decision date: 2000-11-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, 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.