LIQUI-HEME HEMOGLOBIN CALIBRATORS— 510(k) K842668

Name: FDA 510(k) clearance K842668
Creator: U.S. Food and Drug Administration
Published: 1985-03-05

Substantially Equivalent

Biodiagnostic Intl

FDA 510(k) clearance K842668 for LIQUI-HEME HEMOGLOBIN CALIBRATORS, Substantially Equivalent on 1985-03-05. Applicant: Biodiagnostic Intl. Device class: 2.

Clearance details

Applicant: Biodiagnostic Intl
Product code: Code KRZ
Device class: Class 2
Regulation: 21 CFR 864.8165
Advisory panel: Hematology
Date received: 1984-07-10
Decision date: 1985-03-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.