Company · US
Techlab, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1992 to 2019. Name variants (Inc, Corp, punctuation) are merged.
36510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LLH | Reagents, Clostridium Difficile Toxin | 11 |
| MHJ | Cryptosporidium Spp. | 5 |
| DEG | Lactoferrin, Antigen, Antiserum, Control | 4 |
| KHW | Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp. | 4 |
| LQP | Campylobacter Spp. | 4 |
| MHI | Giardia Spp. | 3 |
| LYR | Helicobacter Pylori | 2 |
| GIA | Test, Leukocyte Peroxidase | 1 |
| MCB | Antigen, C. Difficile | 1 |
| NBT | Antibodies, Saccharomyces Cerevisiae (S.Cerevisiae) | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 20, 2019 | K191456 | Campylobacter Quik Chek Techlab, Inc. | LQP |
| Jun 20, 2019 | K191442 | Campylobacter Chek Techlab, Inc. | LQP |
| Aug 21, 2018 | K181400 | H. PYLORI CHEK Techlab, Inc. | LYR |
| Aug 21, 2018 | K181379 | H. PYLORI QUIK CHEK Techlab, Inc. | LYR |
| Jan 22, 2018 | K173219 | CAMPYLOBACTER CHEK Techlab, Inc. | LQP |
| Jan 22, 2018 | K173217 | CAMPYLOBACTER QUIK CHEK Techlab, Inc. | LQP |
| Jul 10, 2017 | K171078 | TRI-COMBO PARASITE SCREEN Techlab, Inc. | MHJ |
| Jun 7, 2017 | K170728 | E. HISTOLYTICA QUIK CHEK Techlab, Inc. | KHW |
| Mar 26, 2009 | K082499 | C. DIFF QUIK CHEK COMPLETE Techlab, Inc. | LLH |
| Apr 26, 2006 | K053572 | C. DIFF QUIK CHEK Techlab, Inc. | MCB |
| Apr 6, 2006 | K051927 | TECHLAB ASCA-CHEK Techlab, Inc. | NBT |
| Nov 17, 2005 | K051929 | GIARDIA/CRYPTOSPORIDIUM CHEK Techlab, Inc. | MHJ |
| Nov 4, 2005 | K052932 | CRYPTOSPORIDIUM II Techlab, Inc. | MHJ |
| Jul 25, 2005 | K050891 | TOX A/B QUICK CHEK Techlab, Inc. | LLH |
| Oct 20, 2004 | K042071 | IBD-SCAN Techlab, Inc. | DEG |
| Nov 4, 2003 | K033274 | GIARDIA II Techlab, Inc. | MHI |
| Jul 11, 2003 | K030992 | C. DIFF CHEK - 60 Techlab, Inc. | LLH |
| Jul 11, 2003 | K030991 | C. DIFF CHEK - 30 Techlab, Inc. | LLH |
| Apr 24, 2003 | K030404 | C. DIFFICILE TOX A/B II Techlab, Inc. | LLH |
| Apr 21, 2003 | K030704 | IBD-QUIK CHEK Techlab, Inc. | DEG |
| Jun 18, 2001 | K011396 | IBD-CHEK Techlab, Inc. | DEG |
| Nov 22, 2000 | K003306 | C. DIFFICILE TOX A/B II Techlab, Inc. | LLH |
| Dec 21, 1999 | K994101 | E. HISTOLYTICA II Techlab, Inc. | KHW |
| May 18, 1998 | K980354 | CRYPTOSPORIDIUM TEST Techlab, Inc. | MHJ |
| Jul 22, 1997 | K971182 | TOX A/B TEST Techlab, Inc. | LLH |
| Nov 29, 1996 | K963135 | GIARDIA CELISA Techlab, Inc. | MHI |
| Aug 30, 1996 | K955895 | E. HISTOLYTICA TEST Techlab, Inc. | KHW |
| Aug 5, 1996 | K955897 | CRYPTO/GIARDIA-CEL IF TEST Techlab, Inc. | MHI |
| Aug 5, 1996 | K955852 | CRYPTO-CEL IF TEST Techlab, Inc. | MHJ |
| Apr 24, 1995 | K951101 | LEUKO-TEST Techlab, Inc. | DEG |
| Mar 9, 1995 | K944791 | ENTAMOEBA TEST Techlab, Inc. | KHW |
| Apr 26, 1994 | K935296 | CLOSTRIDIUM DIFFICILE TOX-B TEST Techlab, Inc. | LLH |
| Feb 3, 1994 | K931241 | FAST'N'FLAMMATORY KIT Techlab, Inc. | GIA |
| Sep 30, 1993 | K931129 | TECHLAB 1-HOUR TOX-A-TEST Techlab, Inc. | LLH |
| Feb 1, 1993 | K923463 | CLOSTRIDIUM DIFFICILE TOXIN/ANTITOXIN KIT Techlab, Inc. | LLH |
| Mar 4, 1992 | K914902 | CLOSTRIDIUM DIFFICILE TOX-A-TEST Techlab, Inc. | LLH |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||