Name: Predicase
Price: 199 USD

K-number	K023362
Device name	FISHER DIAGNOSTICS THROMBOSCREEN 1000; PACIFIC HEMOSTASIS FIBRINOGEN REAGENT PLUS KAOLIN
Applicant	Fisher Diagnostics
Product code	GKP
Device class	Class II
Decision date	Dec 9, 2002
Decision	Substantially Equivalent
Regulation	864.5400

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Source

View the full FDA submission: accessdata.fda.gov

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FISHER DIAGNOSTICS THROMBOSCREEN 1000; PACIFIC HEMOSTASIS FIBRINOGEN REAGENT PLUS KAOLIN

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