Name: Predicase
Price: 199 USD

K-number	K070174
Device name	AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS; ROCHE SCRIPTS FOR CT/NG TEST ACCESSORY
Applicant	Roche Diagnostics Corporation
Product code	MKZ
Device class	Class I
Decision date	Apr 16, 2007
Decision	Substantially Equivalent
Regulation	866.3120

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Source

View the full FDA submission: accessdata.fda.gov

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AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS; ROCHE SCRIPTS FOR CT/NG TEST ACCESSORY

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