K-number	K905643
Device name	BED RED D-DIMER WHOLE BLOOD AGGLUTINATION ASSAY
Applicant	Agen Biomedical , Ltd.
Product code	GHH
Device class	Class II
Decision date	Apr 12, 1991
Decision	Substantially Equivalent
Regulation	864.7320

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BED RED D-DIMER WHOLE BLOOD AGGLUTINATION ASSAY

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