Name: Predicase
Price: 199 USD

K-number	K040445
Device name	ACON PPX ONE STEP PROPOXYPHENE TEST STRIP AND ACON PPX STEP PROPOXYPHENE TEST DEVICE
Applicant	ACON Laboratories, Inc.
Product code	JXN
Device class	Class II
Decision date	May 19, 2004
Decision	Substantially Equivalent
Regulation	862.3700

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Source

View the full FDA submission: accessdata.fda.gov

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ACON PPX ONE STEP PROPOXYPHENE TEST STRIP AND ACON PPX STEP PROPOXYPHENE TEST DEVICE

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