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510(k) K071711

ASCA-CHEK by Techlab Inc., Corporate Research Center — Product Code NBT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 2007
Date Received
June 22, 2007
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 Techlab Inc., Corporate Research Center

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  • K103673 — GIARDIA/ CRYPTOSPORIDIUM QUIK CHEK (August 18, 2011)
  • K071712 — LEUKO EZ VUE (December 4, 2007)

Other clearances for product code NBT

  • K051927 — TECHLAB ASCA-CHEK (April 6, 2006)
  • K051492 — AESKULISA ASCA A (November 14, 2005)
  • K042579 — BINDAZYME HUMAN ASCA IGG AND IGA EIA DIAGNOSTIC TEST KIT (July 28, 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)