CRITERION, HEMOCUE B-HEMOGLOBIN CONTROL— 510(k) K921681

Name: FDA 510(k) clearance K921681
Creator: U.S. Food and Drug Administration
Published: 1992-11-17

Substantially Equivalent

Isolab, Inc.

FDA 510(k) clearance K921681 for CRITERION, HEMOCUE B-HEMOGLOBIN CONTROL, Substantially Equivalent on 1992-11-17. Applicant: Isolab, Inc.. Device class: 2.

Clearance details

Applicant: Isolab, Inc.
Product code: Code GGM
Device class: Class 2
Regulation: 21 CFR 864.8625
Advisory panel: Hematology
Date received: 1992-04-08
Decision date: 1992-11-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Akron, OH, US

Download summary PDF View on FDA.gov ↗

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