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510(k) K940242

VENTANA CEA PRIMARY ANTIBODY by Ventana Medical Systems, Inc. — Product Code DFD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 1996
Date Received
January 19, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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  • K172471 — VENTANA CD30 (Ber-H2) RxDx Assay (May 8, 2018)
  • DEN170030 — VENTANA anti-MLH-1(M1) Mouse Monoclonal Primary Antibody, VENTANA anti-PMS2 (A16 (October 27, 2017)
  • DEN160019 — CINtec Histology (50 tests), CINtec Histology (250 tests) (March 4, 2017)
  • K142965 — Virtuoso System for IHC PR (1E2) using iScan HT (July 16, 2015)
  • K140465 — VIRTUOSO SYSTEM FOR IHC ER (SP1) WITH BENCHMARK ULTRA STAINER (March 20, 2014)
  • K130515 — VIRTUOSO SYSTEM FOR IHC ER (SPI) (November 22, 2013)

Other clearances for product code DFD

  • K924578 — PSA ANTIBODY KIT (February 5, 1993)
  • K924629 — PAP ANTIBODY KIT (February 4, 1993)