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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzymatic Method, Creatinine
510(k) Number K062105
Device Name DIAZYME CREATININE LIQUID REAGENTS ASSAY
Applicant
Diazyme Laboratories
3550 General Atomics Ct.
San Diego,  CA  92121
Applicant Contact Abhijit Datta
Correspondent
Diazyme Laboratories
3550 General Atomics Ct.
San Diego,  CA  92121
Correspondent Contact Abhijit Datta
Regulation Number862.1225
Classification Product Code
JFY  
Subsequent Product Code
JJX  
Date Received07/24/2006
Decision Date 04/23/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
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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