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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name calibrator, secondary
510(k) Number K033860
Device Name AUTOKIT TOTAL KETONE BODIES KIT (SERUM) AND WAKO KETONE BODY CALIBRATOR
Applicant
WAKO CHEMICALS, USA, INC.
1600 BELLWOOD ROAD
RICHMOND,  VA  23237
Applicant Contact TONYA MALLORY
Correspondent
WAKO CHEMICALS, USA, INC.
1600 BELLWOOD ROAD
RICHMOND,  VA  23237
Correspondent Contact TONYA MALLORY
Regulation Number862.1150
Classification Product Code
JIT  
Date Received12/12/2003
Decision Date 04/23/2004
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
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