Stanbio Laboratory: FDA filings under this applicant name
FDA lists 47 510(k) clearances under the applicant name “Stanbio Laboratory” (first 1977, latest 2009), across 39 product codes in 5 review panels. Median 510(k) review time under this name: 60 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 | 0 | — |
| 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 |
|---|---|---|---|
| JHJ | Agglutination Method, Human Chorionic Gonadotropin | 4 | 4 |
| GKR | System, Hemoglobin, Automated | 3 | 3 |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 2 | 2 |
| JIY | Photometric Method, Iron (Non-Heme) | 2 | 2 |
| LDP | Colorimetry, Acetaminophen | 2 | 2 |
| CDH | Acid, Uric, Phosphotungstate Reduction | 1 | 1 |
| CDL | Berthelot Indophenol, Urea Nitrogen | 1 | 1 |
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 1 | 1 |
| CGA | Glucose Oxidase, Glucose | 1 | 1 |
| CGO | Lieberman-Burchard/Abell-Kendall, Colorimetric, Cholesterol | 1 | 1 |
Plus 29 more product codes.
Review panels
- Clinical Chemistry (35)
- Immunology (4)
- Clinical Toxicology (4)
- Hematology (3)
- Microbiology (1)
Most recent Stanbio Laboratory 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K090093 | STANBIO LABORATORY HEMOPOINT H2 DM HEMOGLOBIN MEASUREMENT SYSTEM | GKR | 2009-06-10 | 147 |
| K081719 | STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM | GKR | 2008-07-18 | 30 |
| K050283 | CREATININE LIQUICOLOR | JFY | 2005-06-30 | 143 |
| K050266 | DIRECT BILIRUBIN LIQUICOLOR AND TOTAL BILIRUBIN LIQUICOLOR | JFM | 2005-06-30 | 146 |
| K042169 | STANBIO LABORATORY SIRRUS CLINICAL CHEMISTRY ANALYZER | JJE | 2005-03-14 | 215 |
| K041155 | WIDE RANGE C-REACTIVE PROTEIN (WR CRP) ASSAY | DCK | 2004-10-14 | 164 |
| K032936 | DIRECT LDL CHOLESTEROL LIQUID COLOR AND STANBIO DIRECT HDL/LDL CHOLESTEROL CALIBRATOR | JIX | 2004-03-12 | 172 |
| K032932 | DIRECT HDL-CHOLESTEROL LIQUID COLOR; DIRECT HDL/LDL-CHOLESTEROL CALIBRATOR | LBS | 2004-03-10 | 170 |
| K032482 | STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM | GKR | 2003-10-24 | 73 |
| K020378 | QUPID PLUS E.R. | JHI | 2002-06-21 | 136 |
37 earlier clearances. See the full list in Caduvo.
Recalls
12 product recalls in 6 recall events; 2 initiated in the last five years. Most recent: 2023-10-02.
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 Stanbio Laboratory?
FDA lists 47 510(k) clearances under the applicant name “Stanbio Laboratory” (first 1977, latest 2009), across 39 product codes in 5 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 Stanbio Laboratory?
The median time from FDA receipt to decision across 510(k)s cleared under the name Stanbio Laboratory is 60 days.
Which FDA product codes appear under Stanbio Laboratory?
The most frequent FDA product codes under this applicant name are JHJ (Agglutination Method, Human Chorionic Gonadotropin, 4); GKR (System, Hemoglobin, Automated, 3); CDT (Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides, 2).
Next steps
- See all 47 Stanbio Laboratory clearances with predicates and recalls
- Run predicate analysis for product code JHJ, Stanbio Laboratory'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.