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510(k) K973391

CHEMMATE KAPPA by Ventana Medical Systems, Inc. — Product Code DEM

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

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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)