K-number	K894845
Device name	(CALAS(TM)) W/ADD'L REAGENT CALAS(TM) PRONASE
Applicant	Meridian Diagnostics, Inc.
Product code	GMD
Device class	Class II
Decision date	Sep 8, 1989
Decision	Substantially Equivalent
Regulation	866.3165

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View the full FDA submission: accessdata.fda.gov

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(CALAS(TM)) W/ADD'L REAGENT CALAS(TM) PRONASE

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