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Techlab, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
36
Inspections
5
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K191456Campylobacter Quik ChekJune 20, 2019
K191442Campylobacter ChekJune 20, 2019
K181379H. PYLORI QUIK CHEKAugust 21, 2018
K181400H. PYLORI CHEK™August 21, 2018
K173219CAMPYLOBACTER CHEKJanuary 22, 2018
K173217CAMPYLOBACTER QUIK CHEKJanuary 22, 2018
K171078TRI-COMBO PARASITE SCREENJuly 10, 2017
K170728E. HISTOLYTICA QUIK CHEKJune 7, 2017
K082499C. DIFF QUIK CHEK COMPLETEMarch 26, 2009
K053572C. DIFF QUIK CHEKApril 26, 2006
K051927TECHLAB ASCA-CHEKApril 6, 2006
K051929GIARDIA/CRYPTOSPORIDIUM CHEKNovember 17, 2005
K052932CRYPTOSPORIDIUM IINovember 4, 2005
K050891TOX A/B QUICK CHEKJuly 25, 2005
K042071IBD-SCANOctober 20, 2004
K033274GIARDIA IINovember 4, 2003
K030991C. DIFF CHEK - 30July 11, 2003
K030992C. DIFF CHEK - 60July 11, 2003
K030404C. DIFFICILE TOX A/B IIApril 24, 2003
K030704IBD-QUIK CHEKApril 21, 2003