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510(k) K940583

VENTANA CD45 PRIMARY ANTIBODY by Ventana Medical Systems, Inc. — Product Code DEH

K940583 is an FDA 510(k) premarket notification submitted by Ventana Medical Systems, Inc. for the device "VENTANA CD45 PRIMARY ANTIBODY". The FDA issued a decision of Substantially Equivalent on October 20, 1997. The device falls under product code DEH (Lambda, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5550. Ventana Medical Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 1997
Date Received
February 8, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lambda, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5550
Review Panel
IM
Submission Type

Other clearances by Ventana Medical Systems, Inc.

  • K242783 — Roche Digital Pathology Dx (December 17, 2024)
  • DEN240025 — VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail (08507023001) (December 5, 2024)
  • 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 DEH

  • K172471 — VENTANA CD30 (Ber-H2) RxDx Assay (May 8, 2018)
  • K140396 — FREELITE HUMAN LAMBDA FREE KIT (April 16, 2014)
  • K083601 — LAMBDA LIGHT CHAINS (June 22, 2009)
  • K033811 — FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE OLYMPUS AU ANALYZER (January 30, 2004)
  • K031016 — FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE DAD BEHRING NEPHELOMETE (July 15, 2003)
  • K023131 — FREELITE HUMAN LAMBDA FREE KIT (January 21, 2003)
  • K010440 — FREELITE LAMBDA FREE KIT (April 26, 2001)
  • K010441 — FREELITE KAPPA FREE KIT (April 26, 2001)
  • K003671 — LAMBDA IMMAGE FREELITE KIT (February 1, 2001)
  • K002563 — SHEEP ANTI-HUMAN LAMBDA FREE LIGHT CHAIN IMMUNOFIXATION GRADE KIT (October 26, 2000)

FDA data resources