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510(k) K923768

PULSE CRP TEST by Pulse Scientific, Inc. — Product Code DCK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 1, 1992
Date Received
July 28, 1992
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 Pulse Scientific, Inc.

  • K923767 — PULSE IM RED CELL TEST (October 16, 1992)
  • K923771 — PULSE RF TEST (October 5, 1992)

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