AUTOKIT TOTAL KETONE BODIES KIT (SERUM) AND WAKO KETONE BODY CALIBRATOR

Calibrator, Secondary

WAKO CHEMICALS, USA, INC.

The following data is part of a premarket notification filed by Wako Chemicals, Usa, Inc. with the FDA for Autokit Total Ketone Bodies Kit (serum) And Wako Ketone Body Calibrator.

Pre-market Notification Details

Device IDK033860
510k NumberK033860
Device Name:AUTOKIT TOTAL KETONE BODIES KIT (SERUM) AND WAKO KETONE BODY CALIBRATOR
ClassificationCalibrator, Secondary
Applicant WAKO CHEMICALS, USA, INC. 1600 BELLWOOD ROAD Richmond,  VA  23237
ContactTonya Mallory
CorrespondentTonya Mallory
WAKO CHEMICALS, USA, INC. 1600 BELLWOOD ROAD Richmond,  VA  23237
Product CodeJIT  
CFR Regulation Number862.1150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-12-12
Decision Date2004-04-23

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