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510(k) K973389

CHEMMATE UCHL1 (CD45RO) PREDILUTED ANTIBODY FOR IMMUNOHISTOCHEMICAL STAINING by Ventana Medical Systems, Inc. — Product Code DEM

K973389 is an FDA 510(k) premarket notification submitted by Ventana Medical Systems, Inc. for the device "CHEMMATE UCHL1 (CD45RO) PREDILUTED ANTIBODY FOR IMMUNOHISTOCHEMICAL STAINING". The FDA issued a decision of Substantially Equivalent on October 3, 1997. The device falls under product code DEM (Alpha-1-Antitrypsin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5130. Ventana Medical Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 1997
Date Received
July 10, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alpha-1-Antitrypsin, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5130
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 DEM

  • K123256 — HUMAN ALPHA-1 ANTITRYPSIN KIT SPAPLUS (July 3, 2013)
  • K063610 — DIMENSION VISTA A1AT FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL (January 11, 2007)
  • K053072 — N ANTISERA TO HUMAN ALPHA1-ANTITRYPSIN (March 28, 2006)
  • K052819 — VITROS CHEMISTRY PRODUCTS AAT REAGENT, CALIBRATOR KIT 99 AND AAT PERFORMANCE VER (December 23, 2005)
  • K050596 — QUANTIA A1-AT (May 13, 2005)
  • K031857 — ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAY (September 4, 2003)
  • K011663 — MININEPH A-1 ANTITRYPSIN ANTISERUM, HIGH AND LOW SERUM CONTROLS (July 30, 2001)
  • K010978 — TINA-QUANT ALPHA-1 ANTITRYPSIN (May 18, 2001)
  • K993444 — K-ASSAY ALPHA-1 AT (November 24, 1999)
  • K972640 — TINA-QUANT ALPHA PARTICLE-1-ANTITRYPSIN ASSAY (January 9, 1998)

FDA data resources