Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
Techlab, Inc. — Predicate Candidate Screening
36 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
109 daysmedian FDA review time
223 days90th percentile
36clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K191442 | Campylobacter Chek | Techlab, Inc. | 2019-06-20 | 21 | 0 |
| K191456 | Campylobacter Quik Chek | Techlab, Inc. | 2019-06-20 | 20 | 0 |
| K181379 | H. PYLORI QUIK CHEK | Techlab, Inc. | 2018-08-21 | 89 | 0 |
| K181400 | H. PYLORI CHEK™ | Techlab, Inc. | 2018-08-21 | 84 | 0 |
| K173219 | CAMPYLOBACTER CHEK | Techlab, Inc. | 2018-01-22 | 111 | 0 |
| K173217 | CAMPYLOBACTER QUIK CHEK | Techlab, Inc. | 2018-01-22 | 111 | 0 |
| K171078 | TRI-COMBO PARASITE SCREEN | Techlab, Inc. | 2017-07-10 | 90 | 0 |
| K170728 | E. HISTOLYTICA QUIK CHEK | Techlab, Inc. | 2017-06-07 | 90 | 0 |
| K082499 | C. DIFF QUIK CHEK COMPLETE | Techlab, Inc. | 2009-03-26 | 209 | 0 |
| K053572 | C. DIFF QUIK CHEK | Techlab, Inc. | 2006-04-26 | 125 | 0 |
| K051927 | TECHLAB ASCA-CHEK | Techlab, Inc. | 2006-04-06 | 262 | 0 |
| K051929 | GIARDIA/CRYPTOSPORIDIUM CHEK | Techlab, Inc. | 2005-11-17 | 127 | 0 |
| K052932 | CRYPTOSPORIDIUM II | Techlab, Inc. | 2005-11-04 | 16 | 0 |
| K050891 | TOX A/B QUICK CHEK | Techlab, Inc. | 2005-07-25 | 108 | 0 |
| K042071 | IBD-SCAN | Techlab, Inc. | 2004-10-20 | 79 | 0 |
| K033274 | GIARDIA II | Techlab, Inc. | 2003-11-04 | 25 | 0 |
| K030992 | C. DIFF CHEK - 60 | Techlab, Inc. | 2003-07-11 | 105 | 0 |
| K030991 | C. DIFF CHEK - 30 | Techlab, Inc. | 2003-07-11 | 105 | 0 |
| K030404 | C. DIFFICILE TOX A/B II | Techlab, Inc. | 2003-04-24 | 77 | 0 |
| K030704 | IBD-QUIK CHEK | Techlab, Inc. | 2003-04-21 | 46 | 0 |
| K011396 | IBD-CHEK | Techlab, Inc. | 2001-06-18 | 42 | 0 |
| K003306 | C. DIFFICILE TOX A/B II | Techlab, Inc. | 2000-11-22 | 33 | 0 |
| K994101 | E. HISTOLYTICA II | Techlab, Inc. | 1999-12-21 | 15 | 0 |
| K980354 | CRYPTOSPORIDIUM TEST | Techlab, Inc. | 1998-05-18 | 109 | 0 |
| K971182 | TOX A/B TEST | Techlab, Inc. | 1997-07-22 | 113 | 0 |
| K963135 | GIARDIA CELISA | Techlab, Inc. | 1996-11-29 | 109 | 0 |
| K955895 | E. HISTOLYTICA TEST | Techlab, Inc. | 1996-08-30 | 248 | 0 |
| K955897 | CRYPTO/GIARDIA-CEL IF TEST | Techlab, Inc. | 1996-08-05 | 223 | 0 |
| K955852 | CRYPTO-CEL IF TEST | Techlab, Inc. | 1996-08-05 | 223 | 0 |
| K951101 | LEUKO-TEST | Techlab, Inc. | 1995-04-24 | 45 | 0 |
| K944791 | ENTAMOEBA TEST | Techlab, Inc. | 1995-03-09 | 162 | 0 |
| K935296 | CLOSTRIDIUM DIFFICILE TOX-B TEST | Techlab, Inc. | 1994-04-26 | 174 | 0 |
| K931241 | FAST'N'FLAMMATORY KIT | Techlab, Inc. | 1994-02-03 | 329 | 0 |
| K931129 | TECHLAB 1-HOUR TOX-A-TEST | Techlab, Inc. | 1993-09-30 | 209 | 0 |
| K923463 | CLOSTRIDIUM DIFFICILE TOXIN/ANTITOXIN KIT | Techlab, Inc. | 1993-02-01 | 202 | 0 |
| K914902 | CLOSTRIDIUM DIFFICILE TOX-A-TEST | Techlab, Inc. | 1992-03-04 | 124 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda