Name: Predicase
Price: 199 USD

K-number	K954933
Device name	EKTACHEM CLINICAL CHEMISTRY SLIDE FOR ACETAMINOPHEN
Applicant	Johnson & Johnson Clinical Diagnostics, Inc.
Product code	LDP
Device class	Class II
Decision date	Dec 18, 1995
Decision	Substantially Equivalent
Regulation	862.3030

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Source

View the full FDA submission: accessdata.fda.gov

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EKTACHEM CLINICAL CHEMISTRY SLIDE FOR ACETAMINOPHEN

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