Data / Medical devices / Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica
Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica (JQT): 15 FDA-registered makers in 7 countries
15 establishments in 7 countries are registered with the FDA to make Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica (product code JQT, Class 1, 21 CFR 862.2400). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 18 510(k) clearances under this code, the latest on November 9, 2011, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- JQT
- Device class
- 1
- Regulation
- 862.2400
- Medical specialty
- Clinical Chemistry
Makers by country
| Country | Makers |
|---|---|
| United States | 7 |
| Germany | 3 |
| Norway | 1 |
| China | 1 |
| South Korea | 1 |
| Sweden | 1 |
| France | 1 |
Makers of Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica
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 |
|---|---|---|---|---|---|---|---|---|
| Abbott Diagnostics Technologies AS | Oslo, Norway | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alere San Diego, Inc. | San Diego, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Euroimmun Medizinische Labordiagnostika AG | Luebeck Schleswig-Holstein, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| EUROIMMUN Medizinische Labordiagnostika AG | Dassow Mecklenburg-Western Pomerania, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Helena Laboratories, Corp. | Beaumont, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Infitek Co., Ltd. | Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nano-Ditech Corporation | Cranbury, NJ, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nova Biomedical Corporation | Waltham, MA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nova Biomedical Corporation | Billerica, MA, United States | Manufacturer, Remanufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Precision Biosensor Inc. 2nd Factory | Yuseong-gu Daejeon, South Korea | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Premier Biotech, LLC | Minneapolis, MN, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sanmina-Sci AB | SJALEVAD Vasternorrland, Sweden | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sebia | EVRY Essonne, France | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ucp Biosciences, Inc. | Milpitas, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Viramed Biotech AG | PLANEGG Bavaria, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 9, 2011. 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.