FDA 510(k) Applications Submitted by Techlab, Inc.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K082499 |
08/29/2008 |
C. DIFF QUIK CHEK COMPLETE |
TECHLAB, INC. |
| K030404 |
02/06/2003 |
C. DIFFICILE TOX A/B II |
TECHLAB, INC. |
| K030704 |
03/06/2003 |
IBD-QUIK CHEK |
TECHLAB, INC. |
| K030991 |
03/28/2003 |
C. DIFF CHEK - 30 |
TECHLAB, INC. |
| K030992 |
03/28/2003 |
C. DIFF CHEK - 60 |
TECHLAB, INC. |
| K971182 |
03/31/1997 |
TOX A/B TEST |
TECHLAB, INC. |
| K050891 |
04/08/2005 |
TOX A/B QUICK CHEK |
TECHLAB, INC. |
| K011396 |
05/07/2001 |
IBD-CHEK |
TECHLAB, INC. |
| K051927 |
07/18/2005 |
TECHLAB ASCA-CHEK |
TECHLAB, INC. |
| K042071 |
08/02/2004 |
IBD-SCAN |
TECHLAB, INC. |
| K033274 |
10/10/2003 |
GIARDIA II |
TECHLAB, INC. |
| K052932 |
10/19/2005 |
CRYPTOSPORIDIUM II |
TECHLAB, INC. |
| K003306 |
10/20/2000 |
C. DIFFICILE TOX A/B II |
TECHLAB, INC. |
| K994101 |
12/06/1999 |
E. HISTOLYTICA II |
TECHLAB, INC. |
| K053572 |
12/22/2005 |
C. DIFF QUIK CHEK |
TECHLAB, INC. |
| K955895 |
12/26/1995 |
E. HISTOLYTICA TEST |
TECHLAB, INC. |
| K955897 |
12/26/1995 |
CRYPTO/GIARDIA-CEL IF TEST |
TECHLAB, INC. |
| K980354 |
01/29/1998 |
CRYPTOSPORIDIUM TEST |
TECHLAB, INC. |
| K963135 |
08/12/1996 |
GIARDIA CELISA |
TECHLAB, INC. |
| K955852 |
12/26/1995 |
CRYPTO-CEL IF TEST |
TECHLAB, INC. |
| K051929 |
07/13/2005 |
GIARDIA/CRYPTOSPORIDIUM CHEK |
TECHLAB, INC. |
| K191442 |
05/30/2019 |
Campylobacter Chek |
Techlab, Inc. |
| K170728 |
03/09/2017 |
E. HISTOLYTICA QUIK CHEK |
TECHLAB, Inc. |
| K171078 |
04/11/2017 |
TRI-COMBO PARASITE SCREEN |
Techlab, Inc. |
| K181379 |
05/24/2018 |
H. PYLORI QUIK CHEK |
TECHLAB, Inc. |
| K181400 |
05/29/2018 |
H. PYLORI CHEKÖ |
TECHLAB, Inc. |
| K173217 |
10/03/2017 |
CAMPYLOBACTER QUIK CHEK |
Techlab, Inc. |
| K173219 |
10/03/2017 |
CAMPYLOBACTER CHEK |
Techlab, Inc. |
|
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