K-number	K951638
Device name	AURAFLEX CK-MB 200TEST PACK, CALIBRATOR PACK
Applicant	Organon Teknika Corp.
Product code	JHY
Device class	Class II
Decision date	May 2, 1995
Decision	Substantially Equivalent
Regulation	862.1215

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View the full FDA submission: accessdata.fda.gov

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AURAFLEX CK-MB 200TEST PACK, CALIBRATOR PACK

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