Data / Medical devices / Fluorometric Method, Cpk Or Isoenzymes
Fluorometric Method, Cpk Or Isoenzymes (JHX): 18 FDA-registered makers in 6 countries
18 establishments in 6 countries are registered with the FDA to make Fluorometric Method, Cpk Or Isoenzymes (product code JHX, Class 2, 21 CFR 862.1215). 12 of them have a 510(k) clearance or PMA approval on file and 4 have a recall event. The FDA has issued 48 510(k) clearances under this code, the latest on February 16, 2024, and lists 10 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- JHX
- Device class
- 2
- Regulation
- 862.1215
- Medical specialty
- Clinical Chemistry
Makers by country
| Country | Makers |
|---|---|
| United States | 10 |
| Japan | 3 |
| United Kingdom | 2 |
| Canada | 1 |
| Ireland | 1 |
| Germany | 1 |
Makers of Fluorometric Method, Cpk Or Isoenzymes
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 |
|---|---|---|---|---|---|---|---|---|
| Siemens Healthcare Diagnostics Inc. | Newark, DE, United States | Manufacturer, Specification developer | 3 | September 8, 2005 | 0 | 3 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc | East Walpole, MA, United States | Specification developer | 3 | September 8, 2005 | 0 | 3 | 0 | api.fda.gov |
| Beckman Coulter, Inc. | Chaska, MN, United States | Manufacturer | 2 | February 16, 2024 | 0 | 0 | 0 | api.fda.gov |
| Fisher Diagnostics | Middletown, VA, United States | Specification developer | 1 | July 21, 2004 | 0 | 0 | 0 | api.fda.gov |
| Ortho-Clinical Diagnostics, Inc. | Rochester, NY, United States | Complaint file establishment, Specification developer | 1 | January 28, 2022 | 0 | 1 | 0 | api.fda.gov |
| Ortho-Clinical Diagnostics | Pencoed Bridgend, United Kingdom | Manufacturer | 1 | January 28, 2022 | 0 | 0 | 0 | api.fda.gov |
| PHC Corporation | Tako-machi Katori-gun Chiba, Japan | Complaint file establishment, Specification developer | 1 | August 17, 2009 | 0 | 0 | 0 | api.fda.gov |
| Response Biomedical Corp. | Vancouver British Columbia, Canada | Manufacturer | 1 | May 17, 2004 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Products Limited | LLANBERIS Wales, United Kingdom | Manufacturer | 1 | July 22, 2002 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | Tarrytown, NY, United States | Complaint file establishment, Specification developer | 1 | April 3, 1991 | 0 | 1 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | E Walpole, MA, United States | Manufacturer | 1 | April 3, 1991 | 0 | 0 | 0 | api.fda.gov |
| Tosoh Aia, Inc. | Toyama, Japan | Manufacturer | 1 | September 27, 1991 | 0 | 0 | 0 | api.fda.gov |
| Beckman Coulter Ireland Inc | O CALLAGHANS MILLS Clare, Ireland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Carclo Technical Plastics - Latrobe | Latrobe, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lre Medical GMBH | NOERDLINGEN Bavaria, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nipro Corporation Odate Factory | ODATE-SHI Akita, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Quidel Cardiovascular Inc. | San Diego, CA, United States | Manufacturer, Manufacturer for export, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Scientific Supplies & Technology, Inc. | Doral, FL, United States | Remanufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov |
Updated February 16, 2024. 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.