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510(k) K042579

BINDAZYME HUMAN ASCA IGG AND IGA EIA DIAGNOSTIC TEST KIT by The Binding Site — Product Code NBT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 2005
Date Received
September 22, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antibodies, Saccharomyces Cerevisiae (S.Cerevisiae)
Device Class
Class II
Regulation Number
866.5785
Review Panel
IM
Submission Type

Other clearances by The Binding Site

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  • K140105 — HEVYLITE HUMAN IGA KAPPA KIT FOR USE ON SIEMENS BNII, HEVYLITE HUMAN IGA LAMBDA (March 18, 2014)
  • K132555 — HEVYLITE HUMAN IGG KAPPA KIT AND HEVYLITE HUMAN IGG LAMBDA KIT (December 20, 2013)
  • K103824 — HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPA PLUS (February 27, 2012)
  • K100455 — SPAPLUS ANALYZER (September 3, 2010)
  • K090920 — HUMAN IGG SUBCLASS LIQUID REAGENT KITS (FOR USE ON HITACHI 911/ 912/ 917 AND MOD (December 30, 2009)
  • K092450 — HUMAN IGD KIT FOR USE ON SPAPLUS (December 28, 2009)
  • K083289 — HUMAN BETA-2 MICROGLOBULIN KIT (May 6, 2009)
  • K082129 — HUMAN IGM LIQUID REAGENT KIT FOR USE ON THE SPAPLUS ANALYZER (February 10, 2009)
  • K081827 — HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPAPLUS (December 19, 2008)

Other clearances for product code NBT

  • K071711 — ASCA-CHEK (November 7, 2007)
  • K051927 — TECHLAB ASCA-CHEK (April 6, 2006)
  • K051492 — AESKULISA ASCA A (November 14, 2005)
  • K032850 — IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGG) (March 18, 2004)
  • K032860 — IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGA) (March 18, 2004)
  • K000733 — QUANTA LITE ASCA (S. CEREVISIAE) IGA ELISA (May 21, 2001)
  • DEN000007 — QUANTA LITE ASCA (S. CEREVISIAE) IGG ELISA (August 16, 2000)