Name: Predicase
Price: 199 USD

K-number	K020716
Device name	RAPID OPIATES TEST STRIP II, RAPID OPIATES TEST CARD II AND DOA MULTIPLE DRUG TEST CARDS (UP TO SIX TESTS)
Applicant	Rapid Diagnostics, Inc.
Product code	DJG
Device class	Class II
Decision date	May 6, 2002
Decision	Substantially Equivalent
Regulation	862.3650

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Source

View the full FDA submission: accessdata.fda.gov

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RAPID OPIATES TEST STRIP II, RAPID OPIATES TEST CARD II AND DOA MULTIPLE DRUG TEST CARDS (UP TO SIX TESTS)

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