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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Acid, Folic, Radioimmunoassay
510(k) Number K161646
Device Name Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set
Applicant
Diazyme Laboratories
12889 Gregg Ct.
Poway,  CA  92130
Applicant Contact ABHIJIT DATTA
Correspondent
Diazyme Laboratories
12889 Gregg Ct.
Poway,  CA  92130
Correspondent Contact ABHIJIT DATTA
Regulation Number862.1295
Classification Product Code
CGN  
Subsequent Product Codes
JIT   JJX  
Date Received06/15/2016
Decision Date 11/04/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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