Name: Predicase
Price: 199 USD

K-number	K050799
Device name	TRIAGE(R) D-DIMER CALIBRATION VERIFICATION CONTROLS; TRIAGE(R) D-DIMER CONTROLS
Applicant	Biosite Incorporated
Product code	GGN
Device class	Class II
Decision date	Jun 29, 2005
Decision	Substantially Equivalent
Regulation	864.5425

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Source

View the full FDA submission: accessdata.fda.gov

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TRIAGE(R) D-DIMER CALIBRATION VERIFICATION CONTROLS; TRIAGE(R) D-DIMER CONTROLS

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