CAPILLARY'S HEMOGLOBIN(E) (PN 2007)— 510(k) K052291

Substantially Equivalent

Sebia

FDA 510(k) clearance K052291 for CAPILLARY'S HEMOGLOBIN(E) (PN 2007), Substantially Equivalent on 2006-06-27. Applicant: Sebia.

Clearance details

Applicant: Sebia
Product code: Code GKA
Advisory panel: Hematology
Date received: 2005-08-23
Decision date: 2006-06-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chelsea, MI, US

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