Name: Predicase
Price: 199 USD

K-number	K072142
Device name	S40 CLINICAL ANALYZER, S TEST ALP, S TEST AMYLASE, S TEST AST
Applicant	Alfa Wassermann Diagnostic Technologies, Inc.
Product code	CKF
Device class	Class II
Decision date	Jun 26, 2008
Decision	Substantially Equivalent
Regulation	862.1050

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Source

View the full FDA submission: accessdata.fda.gov

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S40 CLINICAL ANALYZER, S TEST ALP, S TEST AMYLASE, S TEST AST

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