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510(k) K020878

LYPHOCHEK HEMOSTASIS, MODELS 798, 799 by Bio-Rad — Product Code GGC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 2002
Date Received
March 18, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Control, Plasma, Abnormal
Device Class
Class II
Regulation Number
864.5425
Review Panel
HE
Submission Type

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  • K012422 — K-ASSAY D-DIMER CONTROLS (August 21, 2001)
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