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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase
510(k) Number K020484
Device Name CARESIDE LDH
Applicant
CARESIDE, INC.
6100 BRISTOL PKWY.
CULVER CITY,  CA  90230
Applicant Contact KENNETH B ASARCH
Correspondent
CARESIDE, INC.
6100 BRISTOL PKWY.
CULVER CITY,  CA  90230
Correspondent Contact KENNETH B ASARCH
Regulation Number862.1440
Classification Product Code
CFH  
Date Received02/13/2002
Decision Date 07/03/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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