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510(k) K854221

DIESSE CRP TEST KIT by Marvic Interpharma, Inc. — Product Code DCK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 25, 1985
Date Received
October 18, 1985
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

Other clearances by Marvic Interpharma, Inc.

  • K854223 — VES-TEC/VES-MATIC (April 4, 1986)
  • K854222 — DIESSE RF TEST KIT (February 6, 1986)

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