Data / Medical devices / Microscope, Fluorescence/U.V.
Microscope, Fluorescence/U.V. (IBK): 30 FDA-registered makers in 8 countries
30 establishments in 8 countries are registered with the FDA to make Microscope, Fluorescence/U.V. (product code IBK, Class 1, 21 CFR 864.3600). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 1 510(k) clearance under this code, the latest on July 6, 1977, and lists 0 recall events (0 Class I). FDA data exported November 3, 2026.
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- Product code
- IBK
- Device class
- 1
- Regulation
- 864.3600
- Medical specialty
- Pathology
Makers by country
| Country | Makers |
|---|---|
| United States | 8 |
| China | 7 |
| Germany | 5 |
| Japan | 4 |
| India | 3 |
| Taiwan | 1 |
| Italy | 1 |
| South Korea | 1 |
Makers of Microscope, Fluorescence/U.V.
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 |
|---|---|---|---|---|---|---|---|---|
| Accu-Scope, Inc. | Commack, NY, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Apothecaries Sundries MFG Pvt Ltd | GURUGRAM Haryana, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Agilent Technologies, Inc | Santa Clara, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Agilent Technologies, Inc. | Winooski, VT, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CITOTEST Labware Manufacturing CO., LTD. | Haimen Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Citotest Scientific Co.,ltd. | Nanjing Jiangsu, China | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Caliber Imaging & Diagnostics, Inc. | Rochester, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Carl Zeiss Microscopy, GmbH | Jena Thuringia, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Carl Zeiss Suzhou Co., Ltd. | Suzhou Jiangsu, China | 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 | |
| Evident Corporation | Kamiina-gun Nagano, Japan | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Evident Corporation | Hachioji-shi Tokyo, Japan | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Evident Nagano Corporation | Kamiina-gun Nagano, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Heuer International (A division of GST Corporation Limited) | NOIDA Uttar Pradesh, India | Foreign private label distributor, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Immco Diagnostics, Inc. | Williamsville, NY, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Instapath Inc. | Houston, TX, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jellox Biotech Inc. | Hsinchu County Hsinchu(County), Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Medomics Medical Technology Co., Ltd. | Nanjing Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Leica Microsystems CMS GMBH | WETZLAR Hesse, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| LW Scientific, Inc. | Lawrenceville, GA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Leica Instruments (Shanghai) Co., Ltd. | Shanghai, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medical Chemical Corporation | Torrance, CA, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Metasystems GMBH | ALTLUSSHEIM Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nanjing Nikon Jiangnan Optical Instrument Co., Ltd. | Nanjing Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Narang Medical, Ltd. | New Delhi, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nikon Corporation | SHINAGAWA-KU Tokyo, Japan | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Yongxin Optics Co., Ltd. | Ningbo Zhejiang, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Visia Lab SRL | SAN GIOVANNI VALDARNO Arezzo, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vpix Medical, Inc. | Jung-gu Daejeon, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated July 6, 1977. 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.