DIAZYME MYOGLOBIN; ASSAY, CALIBRATOR SET, CONTROL SET— 510(k) K123785

Substantially Equivalent

Diazyme Laboratories

FDA 510(k) clearance K123785 for DIAZYME MYOGLOBIN; ASSAY, CALIBRATOR SET, CONTROL SET, Substantially Equivalent on 2013-06-07. Applicant: Diazyme Laboratories.

Clearance details

Applicant: Diazyme Laboratories
Product code: Code DDR
Advisory panel: Immunology
Date received: 2012-12-10
Decision date: 2013-06-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Poway, CA, US

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