Techlab, Inc.
Blacksburg, VA, US
TECHLAB, INC. appears in FDA device records in Blacksburg, VA. FDA records list 36 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 36 510(k) clearances for Techlab, Inc. between 1992 and 2019. The busiest year on record is 2003, with 5. The most recent is 2019, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1992 | 1 |
| 1993 | 2 |
| 1994 | 2 |
| 1995 | 2 |
| 1996 | 4 |
| 1997 | 1 |
| 1998 | 1 |
| 1999 | 1 |
| 2000 | 1 |
| 2001 | 1 |
| 2003 | 5 |
| 2004 | 1 |
| 2005 | 3 |
| 2006 | 2 |
| 2009 | 1 |
| 2017 | 2 |
| 2018 | 4 |
| 2019 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K191456 | Campylobacter Quik Chek | LQP | Substantially Equivalent | |
| K191442 | Campylobacter Chek | LQP | Substantially Equivalent | |
| K181400 | H. PYLORI CHEK™ | LYR | Substantially Equivalent | |
| K181379 | H. PYLORI QUIK CHEK | LYR | Substantially Equivalent | |
| K173219 | CAMPYLOBACTER CHEK | LQP | Substantially Equivalent | |
| K173217 | CAMPYLOBACTER QUIK CHEK | LQP | Substantially Equivalent | |
| K171078 | TRI-COMBO PARASITE SCREEN | MHJ | Substantially Equivalent | |
| K170728 | E. HISTOLYTICA QUIK CHEK | KHW | Substantially Equivalent | |
| K082499 | C. DIFF QUIK CHEK COMPLETE | LLH | Substantially Equivalent | |
| K053572 | C. DIFF QUIK CHEK | MCB | Substantially Equivalent | |
| K051927 | TECHLAB ASCA-CHEK | NBT | Substantially Equivalent | |
| K051929 | GIARDIA/CRYPTOSPORIDIUM CHEK | MHJ | Substantially Equivalent | |
| K052932 | CRYPTOSPORIDIUM II | MHJ | Substantially Equivalent | |
| K050891 | TOX A/B QUICK CHEK | LLH | Substantially Equivalent | |
| K042071 | IBD-SCAN | DEG | Substantially Equivalent | |
| K033274 | GIARDIA II | MHI | Substantially Equivalent | |
| K030992 | C. DIFF CHEK - 60 | LLH | Substantially Equivalent | |
| K030991 | C. DIFF CHEK - 30 | LLH | Substantially Equivalent | |
| K030404 | C. DIFFICILE TOX A/B II | LLH | Substantially Equivalent | |
| K030704 | IBD-QUIK CHEK | DEG | Substantially Equivalent | |
| K011396 | IBD-CHEK | DEG | Substantially Equivalent | |
| K003306 | C. DIFFICILE TOX A/B II | LLH | Substantially Equivalent | |
| K994101 | E. HISTOLYTICA II | KHW | Substantially Equivalent | |
| K980354 | CRYPTOSPORIDIUM TEST | MHJ | Substantially Equivalent | |
| K971182 | TOX A/B TEST | LLH | Substantially Equivalent | |
| K963135 | GIARDIA CELISA | MHI | Substantially Equivalent | |
| K955895 | E. HISTOLYTICA TEST | KHW | Substantially Equivalent | |
| K955897 | CRYPTO/GIARDIA-CEL IF TEST | MHI | Substantially Equivalent | |
| K955852 | CRYPTO-CEL IF TEST | MHJ | Substantially Equivalent | |
| K951101 | LEUKO-TEST | DEG | Substantially Equivalent | |
| K944791 | ENTAMOEBA TEST | KHW | Substantially Equivalent | |
| K935296 | CLOSTRIDIUM DIFFICILE TOX-B TEST | LLH | Substantially Equivalent | |
| K931241 | FAST'N'FLAMMATORY KIT | GIA | Substantially Equivalent | |
| K931129 | TECHLAB 1-HOUR TOX-A-TEST | LLH | Substantially Equivalent | |
| K923463 | CLOSTRIDIUM DIFFICILE TOXIN/ANTITOXIN KIT | LLH | Substantially Equivalent | |
| K914902 | CLOSTRIDIUM DIFFICILE TOX-A-TEST | LLH | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1122855 | 1000123404 | TECHLAB, INC. | 2001 KRAFT DRIVE, BLACKSBURG, VA 24060 US | 2026 | |
| 3009935129 | 3009935129 | TECHLAB, INC. | 20 Corporate Drive, Radford, VA 24141 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- NBTAntibodies, Saccharomyces Cerevisiae (S.Cerevisiae)
- MCBAntigen, C. Difficile
- KHWAntigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.
- GMZAntigens, All Types, Escherichia Coli
- LQPCampylobacter Spp.
- MHJCryptosporidium Spp.
- MHIGiardia Spp.
- LYRHelicobacter Pylori
- DEGLactoferrin, Antigen, Antiserum, Control
- LLHReagents, Clostridium Difficile Toxin
- GIATest, Leukocyte Peroxidase
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain