Name: Predicase
Price: 199 USD

K-number	K012300
Device name	ACON BZO ONE STEP BENZODIAZEPINES TEST STRIP; ACON BZO ONE STEP BENZODIAZEPINES TEST DEVICE
Applicant	ACON Laboratories, Inc.
Product code	JXM
Device class	Class II
Decision date	Sep 17, 2001
Decision	Substantially Equivalent
Regulation	862.3170

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Source

View the full FDA submission: accessdata.fda.gov

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ACON BZO ONE STEP BENZODIAZEPINES TEST STRIP; ACON BZO ONE STEP BENZODIAZEPINES TEST DEVICE

Everything you need for a 510(k) submission. Nothing you don't.