K-number	K973535
Device name	ACE CARBAMAZEPINE REAGENT/AED CALIBRATORS
Applicant	Schiapparelli Biosystems, Inc.
Product code	KLT
Device class	Class II
Decision date	Oct 20, 1997
Decision	Substantially Equivalent
Regulation	862.3645

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ACE CARBAMAZEPINE REAGENT/AED CALIBRATORS

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