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510(k) K945280

DUPONT DIMENSION C-REACTIVE PROTEIN METHOD by Dupont Medical Products — Product Code DCK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 9, 1995
Date Received
October 28, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
C-Reactive Protein, Antigen, Antiserum, And Control
Device Class
Class II
Regulation Number
866.5270
Review Panel
IM
Submission Type

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  • K942640 — DUPONT DIMENSION AMYLASE METHOD (September 9, 1994)
  • K942241 — DUPONT APC BLOOD COLLECTION CONTAINER WITH THROMBOPLASTIN (August 18, 1994)

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