Name: Predicase
Price: 199 USD

K-number	K033860
Device name	AUTOKIT TOTAL KETONE BODIES KIT (SERUM) AND WAKO KETONE BODY CALIBRATOR
Applicant	Wako Chemicals USA, Inc.
Product code	JIT
Device class	Class II
Decision date	Apr 23, 2004
Decision	Substantially Equivalent
Regulation	862.1150

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Source

View the full FDA submission: accessdata.fda.gov

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

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