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510(k) K920566

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 8, 1992
Date Received
February 7, 1992
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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  • K130515 — VIRTUOSO SYSTEM FOR IHC ER (SPI) (November 22, 2013)

Other clearances for product code DEY

  • K932386 — VENTANA RED DETECTION KIT (August 9, 1993)
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