Data / Medical devices / Chromatographic Separation, Cpk Isoenzymes / United States
FDA-registered makers of Chromatographic Separation, Cpk Isoenzymes in the United States: 6 establishments
6 establishments in the United States are registered with the FDA to make Chromatographic Separation, Cpk Isoenzymes (product code JHT). 3 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 3, 2026.
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- Device
- Chromatographic Separation, Cpk Isoenzymes
- Product code
- JHT
- Country
- United States
Makers of Chromatographic Separation, Cpk Isoenzymes in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Princeton Biomeditech Corp. | Monmouth Jct, NJ, United States | Manufacturer | 1 | May 28, 1999 | 0 | 0 | 0 | api.fda.gov |
| Princeton BioMeditech Corp. | Plainsboro, NJ, United States | Manufacturer | 1 | May 28, 1999 | 0 | 0 | 0 | api.fda.gov |
| Princeton BioMeditech Corp. | Skillman, NJ, United States | Manufacturer | 1 | May 28, 1999 | 0 | 0 | 0 | api.fda.gov |
| Diagnostic Automation/ Cortez Diagnostics Inc,. | Woodland Hills, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nano-Ditech Corporation | Cranbury, NJ, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Siemens Healthcare Diagnostics Inc. | Newark, DE, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 2026. 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.