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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Sodium, Enzymatic Method
510(k) Number K042189
Device Name DIAZYME SODIUM ENZYMATIC ASSAY
Applicant
Diazyme Laboratories
3550 General Atomics Ct.
San Diego,  CA  92121
Applicant Contact HUHAN TRAN
Correspondent
Diazyme Laboratories
3550 General Atomics Ct.
San Diego,  CA  92121
Correspondent Contact HUHAN TRAN
Regulation Number862.1665
Classification Product Code
MZU  
Subsequent Product Codes
JIT   JJX  
Date Received08/12/2004
Decision Date 10/07/2004
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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