Data / Medical devices / Fluorometer
Fluorometer (JZT): 11 FDA-registered makers in 4 countries
11 establishments in 4 countries are registered with the FDA to make Fluorometer (product code JZT, Class 1, 21 CFR 866.4520). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 14 510(k) clearances under this code, the latest on September 5, 1996, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- JZT
- Device class
- 1
- Regulation
- 866.4520
- Medical specialty
- Immunology
Makers by country
| Country | Makers |
|---|---|
| China | 8 |
| Germany | 1 |
| France | 1 |
| South Korea | 1 |
Makers of Fluorometer
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| B.R.A.H.M.S GmbH | HENNIGSDORF Brandenburg, Germany | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cezanne SAS | NIMES Gard, France | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Genrui Biotech Inc | Shenzhen Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Getein Biotech, Inc. | Nanjing Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou Careomedic Tech Co., Ltd. | Hangzhou Zhejiang, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Infitek Co., Ltd. | Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Konsung Medical Technology Co., Ltd. | Danyang Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Labpeak Co.,ltd | Jinan Shandong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Precision Biosensor Inc. 2nd Factory | Yuseong-gu Daejeon, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Scitek Global Co.,ltd | Jinan Shandong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Orient Gene Biotech | Huzhou Zhejiang, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated September 5, 1996. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.