Name: Predicase
Price: 199 USD

K-number	K002174
Device name	DOCUMENT ASSAYED CHEMISTRY CONTROL, LEVELS 1, 2 AND3
Applicant	Casco-Nerl Diagnostics Corporation (Maine)
Product code	JJY
Device class	Class I
Decision date	Aug 22, 2000
Decision	Substantially Equivalent
Regulation	862.1660

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Source

View the full FDA submission: accessdata.fda.gov

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DOCUMENT ASSAYED CHEMISTRY CONTROL, LEVELS 1, 2 AND3

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