STANBIO LABORATORY HEMOPOINT H2 DM HEMOGLOBIN MEASUREMENT SYSTEM— 510(k) K090093

Name: FDA 510(k) clearance K090093
Creator: U.S. Food and Drug Administration
Published: 2009-06-10

Substantially Equivalent

Stanbio Laboratory

FDA 510(k) clearance K090093 for STANBIO LABORATORY HEMOPOINT H2 DM HEMOGLOBIN MEASUREMENT SYSTEM, Substantially Equivalent on 2009-06-10. Applicant: Stanbio Laboratory. Device class: 2.

Clearance details

Applicant: Stanbio Laboratory
Product code: Code GKR
Device class: Class 2
Regulation: 21 CFR 864.5620
Advisory panel: Hematology
Date received: 2009-01-14
Decision date: 2009-06-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Boerne, TX, US

Download summary PDF View on FDA.gov ↗

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