Name: Predicase
Price: 199 USD

K-number	K023946
Device name	ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST CARD, ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST DEVICE
Applicant	ACON Laboratories, Inc.
Product code	DIS
Device class	Class II
Decision date	Feb 5, 2003
Decision	Substantially Equivalent
Regulation	862.3150

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Source

View the full FDA submission: accessdata.fda.gov

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ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST CARD, ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST DEVICE

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