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510(k) K924629

PAP ANTIBODY KIT by Ventana Medical Systems, Inc. — Product Code DFD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 1993
Date Received
September 14, 1992
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

Other clearances by Ventana Medical Systems, Inc.

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  • K232879 — Roche Digital Pathology Dx (VENTANA DP 200) (June 14, 2024)
  • K212176 — CINtec Histology (December 10, 2021)
  • 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

  • K940242 — VENTANA CEA PRIMARY ANTIBODY (December 23, 1996)
  • K924578 — PSA ANTIBODY KIT (February 5, 1993)