K-number	K993276
Device name	SIMPLIFY D-DIMER, MODEL DCGK1
Applicant	Agen Biomedical , Ltd.
Product code	GHH
Device class	Class II
Decision date	Dec 14, 1999
Decision	Substantially Equivalent
Regulation	864.7320

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View the full FDA submission: accessdata.fda.gov

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SIMPLIFY D-DIMER, MODEL DCGK1

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