K121397

Substantially Equivalent

OSOM IFOB 25 TEST AND PATIENT COLLECTION KIT OSOM IFOB CONTROL KIT OSOM IFOB 50 TEST KIT

Applicant: SEKISUI Diagnostics, LLC
Product code: KHE
Advisory panel: Hematology
Date received: 2012-05-09
Decision date: 2012-12-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

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