Name: Predicase
Price: 199 USD

K-number	K041898
Device name	CLINIQA LIQUID QC TDM CONTROLS LEVELS 1,2 & 3/CLINIQA LINICAL TDM CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEM
Applicant	Cliniqa Corporation
Product code	JJX
Device class	Class I
Decision date	Aug 16, 2004
Decision	Substantially Equivalent
Regulation	862.1660

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Source

View the full FDA submission: accessdata.fda.gov

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CLINIQA LIQUID QC TDM CONTROLS LEVELS 1,2 & 3/CLINIQA LINICAL TDM CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEM

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