HEMOCUE HEMOGLOBIN 201DM ANALYZING SYSTEM— 510(k) K041234

Name: FDA 510(k) clearance K041234
Creator: U.S. Food and Drug Administration
Published: 2004-06-10

Substantially Equivalent

Hemocue, Inc.

FDA 510(k) clearance K041234 for HEMOCUE HEMOGLOBIN 201DM ANALYZING SYSTEM, Substantially Equivalent on 2004-06-10. Applicant: Hemocue, Inc.. Device class: 2.

Clearance details

Applicant: Hemocue, Inc.
Product code: Code GKR
Device class: Class 2
Regulation: 21 CFR 864.5620
Advisory panel: Hematology
Date received: 2004-05-10
Decision date: 2004-06-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Potomac, MD, US

Download summary PDF View on FDA.gov ↗

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