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

Name: FDA 510(k) clearance K123785
Creator: U.S. Food and Drug Administration
Published: 2013-06-07

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. Device class: 2.

Clearance details

Applicant: Diazyme Laboratories
Product code: Code DDR
Device class: Class 2
Regulation: 21 CFR 866.5680
Advisory panel: Immunology
Date received: 2012-12-10
Decision date: 2013-06-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Poway, CA, US

Download summary PDF View on FDA.gov ↗

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