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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Myoglobin, Antigen, Antiserum, Control
510(k) Number K123785
Device Name DIAZYME MYOGLOBIN; ASSAY, CALIBRATOR SET, CONTROL SET
Applicant
Diazyme Laboratories
12889 Gregg Court
Poway,  CA  92064
Applicant Contact Abhijit Datta
Correspondent
Diazyme Laboratories
12889 Gregg Court
Poway,  CA  92064
Correspondent Contact Abhijit Datta
Regulation Number866.5680
Classification Product Code
DDR  
Subsequent Product Codes
JIT   JJX  
Date Received12/10/2012
Decision Date 06/07/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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