Name: Predicase
Price: 199 USD

K-number	K020313
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 Co.
Product code	DKZ
Device class	Class II
Decision date	May 8, 2002
Decision	Substantially Equivalent
Regulation	862.3100

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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.