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510(k) K932386

VENTANA RED DETECTION KIT by Ventana Medical Systems, Inc. — Product Code DEY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 9, 1993
Date Received
May 17, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Igm, Peroxidase, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5550
Review Panel
PA
Submission Type

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Other clearances for product code DEY

  • K920600 — DAB DETECTION KIT (May 11, 1992)
  • K920566 — AEC DETECTION KIT (May 8, 1992)