Techlab, Inc.: FDA clearances and approvals
Techlab, Inc. has 36 FDA 510(k) clearances (first 1992, latest 2019), across 10 product codes in 3 review panels. Median 510(k) review time: 108 days. Since 2017 its median was 90 days, against 90 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 2 | 90 |
| 2018 | 4 | 100 |
| 2019 | 2 | 20 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Techlab, Inc.'s cleared 510(k)s took a median 90 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 90 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LLH | Reagents, Clostridium Difficile Toxin | 11 | 11 |
| MHJ | Cryptosporidium Spp. | 5 | 5 |
| DEG | Lactoferrin, Antigen, Antiserum, Control | 4 | 4 |
| KHW | Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp. | 4 | 4 |
| LQP | Campylobacter Spp. | 4 | 4 |
| MHI | Giardia Spp. | 3 | 3 |
| LYR | Helicobacter Pylori | 2 | 2 |
| GIA | Test, Leukocyte Peroxidase | 1 | 1 |
| MCB | Antigen, C. Difficile | 1 | 1 |
| NBT | Antibodies, Saccharomyces Cerevisiae (S.Cerevisiae) | 1 | 1 |
Review panels
- Microbiology (30)
- Immunology (5)
- Pathology (1)
Most recent Techlab, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K191456 | Campylobacter Quik Chek | LQP | 2019-06-20 | 20 |
| K191442 | Campylobacter Chek | LQP | 2019-06-20 | 21 |
| K181400 | H. PYLORI CHEK | LYR | 2018-08-21 | 84 |
| K181379 | H. PYLORI QUIK CHEK | LYR | 2018-08-21 | 89 |
| K173219 | CAMPYLOBACTER CHEK | LQP | 2018-01-22 | 111 |
| K173217 | CAMPYLOBACTER QUIK CHEK | LQP | 2018-01-22 | 111 |
| K171078 | TRI-COMBO PARASITE SCREEN | MHJ | 2017-07-10 | 90 |
| K170728 | E. HISTOLYTICA QUIK CHEK | KHW | 2017-06-07 | 90 |
| K082499 | C. DIFF QUIK CHEK COMPLETE | LLH | 2009-03-26 | 209 |
| K053572 | C. DIFF QUIK CHEK | MCB | 2006-04-26 | 125 |
26 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Techlab, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Techlab, Inc. have?
Techlab, Inc. has 36 FDA 510(k) clearances (first 1992, latest 2019), across 10 product codes in 3 review panels.
How long does FDA take to clear Techlab, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Techlab, Inc.'s cleared 510(k)s is 108 days. Since 2017: 90 days, versus 90 days for all cleared 510(k)s in the same product codes.
What devices does Techlab, Inc. make?
Its most frequent FDA product codes are LLH (Reagents, Clostridium Difficile Toxin, 11); MHJ (Cryptosporidium Spp., 5); DEG (Lactoferrin, Antigen, Antiserum, Control, 4).
Has Techlab, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Techlab, Inc. Related entities may recall under other names.
Next steps
- See all 36 Techlab, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LLH, Techlab, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.