Data / Medical devices / Column Chromatography & Color Development, Hydroxyproline
Column Chromatography & Color Development, Hydroxyproline (JMM): 8 FDA-registered makers in 3 countries
8 establishments in 3 countries are registered with the FDA to make Column Chromatography & Color Development, Hydroxyproline (product code JMM, Class 1, 21 CFR 862.1400). 6 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 21 510(k) clearances under this code, the latest on July 30, 2001, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- JMM
- Device class
- 1
- Regulation
- 862.1400
- Medical specialty
- Clinical Chemistry
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| United Kingdom | 3 |
| Germany | 1 |
Makers of Column Chromatography & Color Development, Hydroxyproline
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. | Athens, OH, United States | Complaint file establishment, Manufacturer | 2 | August 13, 1998 | 0 | 0 | 0 | api.fda.gov |
| Immunodiagnostic Systems Ltd. | Boldon Colliery Durham, United Kingdom | Manufacturer | 1 | July 9, 1999 | 0 | 1 | 0 | api.fda.gov |
| Ortho-Clinical Diagnostics, Inc. | Rochester, NY, United States | Complaint file establishment, Specification developer | 1 | January 29, 1999 | 0 | 0 | 0 | api.fda.gov |
| Ortho-Clinical Diagnostics | Pencoed Bridgend, United Kingdom | Manufacturer | 1 | January 29, 1999 | 0 | 0 | 0 | api.fda.gov |
| Roche Diagnostics GMBH | MANNHEIM Baden-Wurttemberg, Germany | Manufacturer | 1 | July 24, 2000 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Products Limited | LLANBERIS Wales, United Kingdom | Manufacturer | 1 | May 1, 1998 | 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 | |
| Zeus Scientific LLC | Branchburg, NJ, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated July 30, 2001. 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.