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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name urease, photometric, urea nitrogen
510(k) Number K972012
Device Name CHOLESTECH BUN/CREATININE TEST SYSTEM
Applicant
CHOLESTECH CORP.
3347 INVESTMENT BLVD.
HAYWARD,  CA  94545
Applicant Contact GARY HEWETT
Correspondent
CHOLESTECH CORP.
3347 INVESTMENT BLVD.
HAYWARD,  CA  94545
Correspondent Contact GARY HEWETT
Regulation Number862.1770
Classification Product Code
CDN  
Subsequent Product Code
JFY  
Date Received05/30/1997
Decision Date 07/24/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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