Medical Device Manufacturer · US , Blacksburg , VA

Techlab, Inc.

36 submissions · 36 cleared · Since 1992
36
Total
36
Cleared
0
Denied

Techlab, Inc. — FDA 510(k) Submissions

Techlab, Inc. has submitted 36 FDA 510(k) premarket notifications since 1992, of which 36 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Reagents, Clostridium Difficile Toxin, Cryptosporidium Spp., Lactoferrin, Antigen, Antiserum, Control, Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp., Campylobacter Spp. . Use the specialty filter in the sidebar to narrow results.

36 devices
1–25 of 36
Campylobacter Chek
K191442 · LQP Campylobacter Spp. · Microbiology
Jun 2019 21d
Campylobacter Quik Chek
K191456 · LQP Campylobacter Spp. · Microbiology
Jun 2019 20d
H. PYLORI QUIK CHEK
K181379 · LYR Helicobacter Pylori · Microbiology
Aug 2018 89d
H. PYLORI CHEK?
K181400 · LYR Helicobacter Pylori · Microbiology
Aug 2018 84d
CAMPYLOBACTER QUIK CHEK
K173217 · LQP Campylobacter Spp. · Microbiology
Jan 2018 111d
CAMPYLOBACTER CHEK
K173219 · LQP Campylobacter Spp. · Microbiology
Jan 2018 111d
TRI-COMBO PARASITE SCREEN
K171078 · MHJ Cryptosporidium Spp. · Microbiology
Jul 2017 90d
E. HISTOLYTICA QUIK CHEK
K170728 · KHW Antigen, Id, Ha, Cep,... · Microbiology
Jun 2017 90d
C. DIFF QUIK CHEK COMPLETE
K082499 · LLH Reagents, Clostridium... · Microbiology
Mar 2009 209d
C. DIFF QUIK CHEK
K053572 · MCB Antigen, C. Difficile · Microbiology
Apr 2006 125d
TECHLAB ASCA-CHEK
K051927 · NBT Antibodies, Saccharomyces... · Immunology
Apr 2006 262d
GIARDIA/CRYPTOSPORIDIUM CHEK
K051929 · MHJ Cryptosporidium Spp. · Microbiology
Nov 2005 127d
CRYPTOSPORIDIUM II
K052932 · MHJ Cryptosporidium Spp. · Microbiology
Nov 2005 16d
TOX A/B QUICK CHEK
K050891 · LLH Reagents, Clostridium... · Microbiology
Jul 2005 108d
IBD-SCAN
K042071 · DEG Lactoferrin, Antigen,... · Immunology
Oct 2004 79d
GIARDIA II
K033274 · MHI Giardia Spp. · Microbiology
Nov 2003 25d
C. DIFF CHEK - 30
K030991 · LLH Reagents, Clostridium... · Microbiology
Jul 2003 105d
C. DIFF CHEK - 60
K030992 · LLH Reagents, Clostridium... · Microbiology
Jul 2003 105d
C. DIFFICILE TOX A/B II
K030404 · LLH Reagents, Clostridium... · Microbiology
Apr 2003 77d
IBD-QUIK CHEK
K030704 · DEG Lactoferrin, Antigen,... · Immunology
Apr 2003 46d
IBD-CHEK
K011396 · DEG Lactoferrin, Antigen,... · Immunology
Jun 2001 42d
C. DIFFICILE TOX A/B II
K003306 · LLH Reagents, Clostridium... · Microbiology
Nov 2000 33d
E. HISTOLYTICA II
K994101 · KHW Antigen, Id, Ha, Cep,... · Microbiology
Dec 1999 15d
CRYPTOSPORIDIUM TEST
K980354 · MHJ Cryptosporidium Spp. · Microbiology
May 1998 109d
TOX A/B TEST
K971182 · LLH Reagents, Clostridium... · Microbiology
Jul 1997 113d
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