CRIT-LINE ANEMIA MANAGEMENT SOFTWARE— 510(k) K093834

Name: FDA 510(k) clearance K093834
Creator: U.S. Food and Drug Administration
Published: 2010-09-29

Substantially Equivalent

Hema Metrics, LLC

FDA 510(k) clearance K093834 for CRIT-LINE ANEMIA MANAGEMENT SOFTWARE, Substantially Equivalent on 2010-09-29. Applicant: Hema Metrics, LLC. Device class: 1.

Clearance details

Applicant: Hema Metrics, LLC
Product code: Code MSQ
Device class: Class 1
Regulation: 21 CFR 866.3110
Advisory panel: Microbiology
Date received: 2009-12-14
Decision date: 2010-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ogden, UT, US

Download summary PDF View on FDA.gov ↗

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