Lin-Zhi International, Inc.: FDA filings under this applicant name
FDA lists 49 510(k) clearances under the applicant name “Lin-Zhi International, Inc.” (first 2002, latest 2026), plus 1 De Novo decision, across 16 product codes in 1 review panel. Median 510(k) review time under this name: 80 days. Since 2017 the median was 58 days, against 144 days for all cleared 510(k)s in the same product codes. 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 | 3 | 56 |
| 2013 | 0 | — |
| 2014 | 4 | 162 |
| 2015 | 2 | 326 |
| 2016 | 0 | — |
| 2017 | 1 | 136 |
| 2018 | 1 | 216 |
| 2019 | 2 | 60 |
| 2020 | 3 | 29 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 20 |
| 2026 | 1 | 115 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Lin-Zhi International, Inc. took a median 58 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 144 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DJG | Enzyme Immunoassay, Opiates | 16 | 16 |
| DJR | Enzyme Immunoassay, Methadone | 5 | 5 |
| DKZ | Enzyme Immunoassay, Amphetamine | 5 | 5 |
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | 4 | 4 |
| DLJ | Calibrators, Drug Specific | 3 | 3 |
| LAF | Gas Chromatography, Methamphetamine | 3 | 3 |
| LDJ | Enzyme Immunoassay, Cannabinoids | 3 | 3 |
| DIS | Enzyme Immunoassay, Barbiturate | 2 | 2 |
| DKB | Calibrators, Drug Mixture | 2 | 2 |
| DIC | Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method | 1 | 1 |
Plus 6 more product codes.
Review panels
- Clinical Toxicology (50)
Most recent Lin-Zhi International, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253082 | LZI Buprenorphine II Enzyme Immunoassay | DJG | 2026-01-16 | 115 |
| K251634 | LZI Fentanyl III Enzyme Immunoassay | DJG | 2025-06-18 | 20 |
| K202007 | LZI Oxycodone III Enzyme Immunoassay | DJG | 2020-09-17 | 58 |
| K201938 | LZI Fentanyl II Enzyme Immunoassay | DJG | 2020-08-07 | 25 |
| K201223 | LZI Tramadol Enzyme Immunoassay | DJG | 2020-06-04 | 29 |
| K192299 | LZI Cotinine II Enzyme Immunoassay | MKU | 2019-11-21 | 90 |
| K192433 | LZI Methadone II Enzyme Immunoassay | DJR | 2019-10-04 | 29 |
| K181159 | LZI Fentanyl Enzyme Immunoassay | DJG | 2018-12-03 | 216 |
| K170416 | LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) Calibrators | DJR | 2017-06-26 | 136 |
| K141320 | LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid Cannabinoids Calibrators and LZI Oral Fluid Cannabinoids Controls | LDJ | 2015-05-28 | 373 |
39 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN170010 | De Novo | Meprobamate Test System | 2018-04-20 |
Recalls
9 product recalls in 8 recall events; 0 initiated in the last five years. Most recent: 2019-01-11.
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 Lin-Zhi International, Inc.?
FDA lists 49 510(k) clearances under the applicant name “Lin-Zhi International, Inc.” (first 2002, latest 2026), plus 1 De Novo decision, across 16 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Lin-Zhi International, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Lin-Zhi International, Inc. is 80 days. Since 2017: 58 days, versus 144 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Lin-Zhi International, Inc.?
The most frequent FDA product codes under this applicant name are DJG (Enzyme Immunoassay, Opiates, 16); DJR (Enzyme Immunoassay, Methadone, 5); DKZ (Enzyme Immunoassay, Amphetamine, 5).
Next steps
- See all 49 Lin-Zhi International, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DJG, Lin-Zhi International, 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.