Name: Predicase
Price: 199 USD

K-number	K080739
Device name	ABBOTT REALTIME CT/NG ASSAY AND MULTI-COLLECT SPECIMEN COLLECTION KIT
Applicant	Abbott Molecular, Inc.
Product code	MKZ
Device class	Class I
Decision date	Jul 10, 2008
Decision	Substantially Equivalent
Regulation	866.3120

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Source

View the full FDA submission: accessdata.fda.gov

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ABBOTT REALTIME CT/NG ASSAY AND MULTI-COLLECT SPECIMEN COLLECTION KIT

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