Name: Predicase
Price: 199 USD

K-number	K070921
Device name	BIONEXIA HCG PREGNANCY CASSETTE AND DIPSTICK TESTS, MODEL 08-HCG AND 02-HCG
Applicant	Applied Dna Technologies, Inc.
Product code	JHI
Device class	Class II
Decision date	Jun 29, 2007
Decision	Substantially Equivalent
Regulation	862.1155

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Source

View the full FDA submission: accessdata.fda.gov

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BIONEXIA HCG PREGNANCY CASSETTE AND DIPSTICK TESTS, MODEL 08-HCG AND 02-HCG

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