Techlab, Inc.
Medical device manufacturer in Blacksburg, VA.
36510(k) clearances
0PMA approvals
0recalls
Device types
- LLH Reagents, Clostridium Difficile Toxin 11
- MHJ Cryptosporidium Spp. 5
- KHW Antigen, Id, Ha, Cep, Entamoeba Histolytica… 4
- DEG Lactoferrin, Antigen, Antiserum, Control 4
- LQP Campylobacter Spp. 4
- MHI Giardia Spp. 3
- LYR Helicobacter Pylori 2
- GIA Test, Leukocyte Peroxidase 1
- NBT Antibodies, Saccharomyces Cerevisiae… 1
- MCB Antigen, C. Difficile 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K191456 | Campylobacter Quik ChekLQP · Special | 06/20/2019SE |
| K191442 | Campylobacter ChekLQP · Special | 06/20/2019SE |
| K181400 | H. Pylori ChekLYR · Traditional | 08/21/2018SE |
| K181379 | H. Pylori Quik ChekLYR · Traditional | 08/21/2018SE |
| K173219 | Campylobacter ChekLQP · Traditional | 01/22/2018SE |
| K173217 | Campylobacter Quik ChekLQP · Traditional | 01/22/2018SE |
| K171078 | Tri-Combo Parasite ScreenMHJ · Traditional | 07/10/2017SE |
| K170728 | E. Histolytica Quik ChekKHW · Traditional | 06/07/2017SE |
| K082499 | C. Diff Quik Chek CompleteLLH · Traditional | 03/26/2009SE |
| K053572 | C. Diff Quik ChekMCB · Traditional | 04/26/2006SE |
| K051927 | Techlab Asca-ChekNBT · Traditional | 04/06/2006SE |
| K051929 | Giardia/Cryptosporidium ChekMHJ · Traditional | 11/17/2005SE |
| K052932 | Cryptosporidium IIMHJ · Special | 11/04/2005SE |
| K050891 | Tox A/B Quick ChekLLH · Traditional | 07/25/2005SE |
| K042071 | Ibd-ScanDEG · Traditional | 10/20/2004SE |
| K033274 | Giardia IIMHI · Special | 11/04/2003SE |
| K030992 | C. Diff Chek - 60LLH · Traditional | 07/11/2003SE |
| K030991 | C. Diff Chek - 30LLH · Traditional | 07/11/2003SE |
| K030404 | C. Difficile Tox A/B IILLH · Traditional | 04/24/2003SE |
| K030704 | Ibd-Quik ChekDEG · Traditional | 04/21/2003SE |
| K011396 | Ibd-ChekDEG · Traditional | 06/18/2001SE |
| K003306 | C. Difficile Tox A/B IILLH · Special | 11/22/2000SE |
| K994101 | E. Histolytica IIKHW · Special | 12/21/1999SE |
| K980354 | Cryptosporidium TestMHJ · Traditional | 05/18/1998SE |
| K971182 | Tox A/B TestLLH · Traditional | 07/22/1997SE |
| K963135 | Giardia CelisaMHI · Traditional | 11/29/1996SE |
| K955895 | E. Histolytica TestKHW · Traditional | 08/30/1996SE |
| K955897 | Crypto/Giardia-Cel If TestMHI · Traditional | 08/05/1996SE |
| K955852 | Crypto-Cel If TestMHJ · Traditional | 08/05/1996SE |
| K951101 | Leuko-TestDEG · Traditional | 04/24/1995SE |
| K944791 | Entamoeba TestKHW · Traditional | 03/09/1995SE |
| K935296 | Clostridium Difficile Tox-B TestLLH · Traditional | 04/26/1994SE |
| K931241 | Fast'N'Flammatory KitGIA · Traditional | 02/03/1994SE |
| K931129 | Techlab 1-HOUR Tox-A-TestLLH · Traditional | 09/30/1993SE |
| K923463 | Clostridium Difficile Toxin/Antitoxin KitLLH · Traditional | 02/01/1993SE |
| K914902 | Clostridium Difficile Tox-A-TestLLH · Traditional | 03/04/1992SE |