Name: Predicase
Price: 199 USD

K-number	K010973
Device name	DIASCREEN 50 URINE CHEMISTRY ANALYZER, MODEL # 1242-00; DIASCREEN REAGENT STRIP FOR URINALYSIS, CAT. # D11000
Applicant	Hypoguard USA, Inc.
Product code	JIL
Device class	Class II
Decision date	Sep 11, 2001
Decision	Substantially Equivalent
Regulation	862.1340

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Source

View the full FDA submission: accessdata.fda.gov

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DIASCREEN 50 URINE CHEMISTRY ANALYZER, MODEL # 1242-00; DIASCREEN REAGENT STRIP FOR URINALYSIS, CAT. # D11000

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