Chemtron Biotech, Inc.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Chemtron Biotech, Inc.” (first 2011, latest 2023), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 104 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 | 36 |
| 2013 | 2 | 98 |
| 2014 | 2 | 60 |
| 2015 | 1 | 120 |
| 2016 | 1 | 167 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 104 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Chemtron Biotech, Inc. took a median 104 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 150 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DJG | Enzyme Immunoassay, Opiates | 4 | 4 |
| DKZ | Enzyme Immunoassay, Amphetamine | 3 | 3 |
| JXM | Enzyme Immunoassay, Benzodiazepine | 2 | 2 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 1 | 1 |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | 1 | 1 |
Review panels
Most recent Chemtron Biotech, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K232736 | Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® Drug Screen Fentanyl/Tramadol Dip Card Test, Chemtrue® Multi-Panel Drug Screen Cup Test, Chemtrue® Multi-Panel Drug Screen Dip Card Test | DJG | 2023-12-20 | 104 |
| K153192 | Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel Drug Screen Dip Card/Cup with OPI 2000 Tests | DJG | 2016-04-18 | 167 |
| K143599 | Chemtrue Drug Screen Cup Tests and Chemtrue Drug Screen Cup Tests with OPI 2000 | DJG | 2015-04-17 | 120 |
| K142580 | Chemtrue Multi-Panel DOA DIP Card Tests | DKZ | 2014-12-01 | 77 |
| K142396 | Chemtrue BUP/TCA Single/Multi-Panel Drug Screen Dip Card/Cup/Cassette Tests | DJG | 2014-10-09 | 43 |
| K131931 | CHEMTRUE(R) HCG PREGNANCY URINE MIDSTREAM TEST | LCX | 2013-07-26 | 29 |
| K123844 | CHEMTRUE HCG PREGNANCY URINE DIPSTICK, HCG PREGNANCY URINE CASSETTE TEST, AND HCG COMBO SERUM/URINE CASSETTE TEST | JHI | 2013-05-30 | 168 |
| K123080 | CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN DIP CARD/ CASSETTE TESTS | JXM | 2012-11-29 | 59 |
| K121339 | CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN DIP CARD/CASSETTE TESTS | DKZ | 2012-05-17 | 14 |
| K111322 | CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN CASSETTE/DIPCARD | JXM | 2011-09-14 | 126 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Chemtron Biotech, Inc..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Chemtron Biotech, Inc.?
FDA lists 11 510(k) clearances under the applicant name “Chemtron Biotech, Inc.” (first 2011, latest 2023), across 5 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 Chemtron Biotech, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Chemtron Biotech, Inc. is 104 days.
Which FDA product codes appear under Chemtron Biotech, Inc.?
The most frequent FDA product codes under this applicant name are DJG (Enzyme Immunoassay, Opiates, 4); DKZ (Enzyme Immunoassay, Amphetamine, 3); JXM (Enzyme Immunoassay, Benzodiazepine, 2).
Next steps
- See all 11 Chemtron Biotech, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DJG, Chemtron Biotech, Inc.'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.