Techlab Inc., Corporate Research Center: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Techlab Inc., Corporate Research Center” (first 2007, latest 2012), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 148 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 146 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GMZ | Antigens, All Types, Escherichia Coli | 2 | 2 |
| DEG | Lactoferrin, Antigen, Antiserum, Control | 1 | 1 |
| MHI | Giardia Spp. | 1 | 1 |
| NBT | Antibodies, Saccharomyces Cerevisiae (S.Cerevisiae) | 1 | 1 |
Review panels
- Microbiology (3)
- Immunology (2)
Most recent Techlab Inc., Corporate Research Center 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K121411 | SHIGA TOXIN CHEK | GMZ | 2012-10-02 | 144 |
| K121364 | SHIGA TOXIN QUIK CHEK | GMZ | 2012-10-02 | 148 |
| K103673 | GIARDIA/ CRYPTOSPORIDIUM QUIK CHEK | MHI | 2011-08-18 | 245 |
| K071712 | LEUKO EZ VUE | DEG | 2007-12-04 | 165 |
| K071711 | ASCA-CHEK | NBT | 2007-11-07 | 138 |
Recalls
openFDA lists no recalls under a recalling firm named Techlab Inc., Corporate Research Center.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Techlab, Inc. (36 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Techlab Inc., Corporate Research Center?
FDA lists 5 510(k) clearances under the applicant name “Techlab Inc., Corporate Research Center” (first 2007, latest 2012), across 4 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Techlab Inc., Corporate Research Center?
The median time from FDA receipt to decision across 510(k)s cleared under the name Techlab Inc., Corporate Research Center is 148 days.
Which FDA product codes appear under Techlab Inc., Corporate Research Center?
The most frequent FDA product codes under this applicant name are GMZ (Antigens, All Types, Escherichia Coli, 2); DEG (Lactoferrin, Antigen, Antiserum, Control, 1); MHI (Giardia Spp., 1).
Next steps
- See all 5 Techlab Inc., Corporate Research Center clearances with predicates and recalls
- Run predicate analysis for product code GMZ, Techlab Inc., Corporate Research Center's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.