Data / Medical devices / Differential Rate Kinetic Method, Cpk Or Isoenzymes
Differential Rate Kinetic Method, Cpk Or Isoenzymes (JHS): 9 FDA-registered makers in 4 countries
9 establishments in 4 countries are registered with the FDA to make Differential Rate Kinetic Method, Cpk Or Isoenzymes (product code JHS, Class 2, 21 CFR 862.1215). 7 of them have a 510(k) clearance or PMA approval on file and 3 have a recall event. The FDA has issued 38 510(k) clearances under this code, the latest on May 25, 2016, and lists 5 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- JHS
- Device class
- 2
- Regulation
- 862.1215
- Medical specialty
- Clinical Chemistry
Makers by country
| Country | Makers |
|---|---|
| United States | 5 |
| Germany | 2 |
| Italy | 1 |
| Switzerland | 1 |
Makers of Differential Rate Kinetic 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 |
|---|---|---|---|---|---|---|---|---|
| Ortho-Clinical Diagnostics, Inc. | Rochester, NY, United States | Complaint file establishment, Specification developer | 1 | June 27, 1986 | 0 | 1 | 0 | api.fda.gov |
| Ortho-Clinical Diagnostics, Inc. | Rochester, NY, United States | Manufacturer | 1 | June 27, 1986 | 0 | 1 | 0 | api.fda.gov |
| Roche Diagnostics GMBH | MANNHEIM Baden-Wurttemberg, Germany | Exporter to the US, Manufacturer, Repackager or relabeler, Specification developer | 1 | May 25, 2016 | 0 | 0 | 0 | api.fda.gov |
| Sentinel CH. SPA | Milano, Italy | Manufacturer | 1 | August 19, 2011 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | Newark, DE, United States | Manufacturer, Specification developer | 1 | August 21, 2006 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | Tarrytown, NY, United States | Complaint file establishment, Specification developer | 1 | June 21, 1996 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | E Walpole, MA, United States | Manufacturer | 1 | June 21, 1996 | 0 | 1 | 0 | api.fda.gov |
| Roche Diagnostics GMBH | PENZBERG Bavaria, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Roche Diagnostics International Ltd. | ROTKREUZ Zug, Switzerland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated May 25, 2016. 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.