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510(k) K051927

TECHLAB ASCA-CHEK by Techlab, Inc. — Product Code NBT

K051927 is an FDA 510(k) premarket notification submitted by Techlab, Inc. for the device "TECHLAB ASCA-CHEK". The FDA issued a decision of Substantially Equivalent on April 6, 2006. The device falls under product code NBT (Antibodies, Saccharomyces Cerevisiae (S.Cerevisiae)), a Class II device regulated under 21 CFR 866.5785. Techlab, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 6, 2006
Date Received
July 18, 2005
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.

  • K191442 — Campylobacter Chek (June 20, 2019)
  • K191456 — Campylobacter Quik Chek (June 20, 2019)
  • K181400 — H. PYLORI CHEK™ (August 21, 2018)
  • K181379 — H. PYLORI QUIK CHEK (August 21, 2018)
  • K173217 — CAMPYLOBACTER QUIK CHEK (January 22, 2018)
  • K173219 — CAMPYLOBACTER CHEK (January 22, 2018)
  • K171078 — TRI-COMBO PARASITE SCREEN (July 10, 2017)
  • K170728 — E. HISTOLYTICA QUIK CHEK (June 7, 2017)
  • K082499 — C. DIFF QUIK CHEK COMPLETE (March 26, 2009)
  • K053572 — C. DIFF QUIK CHEK (April 26, 2006)

Other clearances for product code NBT

  • K071711 — ASCA-CHEK (November 7, 2007)
  • 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)

FDA data resources