Data / Medical devices / Colorimetry, Acetaminophen
Colorimetry, Acetaminophen (LDP): 13 FDA-registered makers in 4 countries
13 establishments in 4 countries are registered with the FDA to make Colorimetry, Acetaminophen (product code LDP, Class 2, 21 CFR 862.3030). 8 of them have a 510(k) clearance or PMA approval on file and 4 have a recall event. The FDA has issued 37 510(k) clearances under this code, the latest on July 24, 2026, and lists 11 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- LDP
- Device class
- 2
- Regulation
- 862.3030
- Medical specialty
- Clinical Toxicology
Makers by country
| Country | Makers |
|---|---|
| United States | 9 |
| Germany | 2 |
| Canada | 1 |
| Switzerland | 1 |
Makers of Colorimetry, Acetaminophen
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 | 5 | July 24, 2026 | 0 | 1 | 0 | api.fda.gov |
| Sekisui Diagnostics P.E.I. Inc. | CHARLOTTETOWN Prince Edward Island, Canada | Contract manufacturer, Manufacturer | 4 | February 18, 2022 | 0 | 1 | 0 | api.fda.gov |
| Beckman Coulter, Inc. | Brea, CA, United States | Specification developer | 2 | June 8, 2001 | 0 | 3 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | Tarrytown, NY, United States | Complaint file establishment, Specification developer | 2 | July 24, 2026 | 0 | 0 | 0 | api.fda.gov |
| Microgenics Corporation | Fremont, CA, United States | Manufacturer | 1 | July 8, 1996 | 0 | 0 | 0 | api.fda.gov |
| Ortho-Clinical Diagnostics, Inc. | Rochester, NY, United States | Complaint file establishment, Specification developer | 1 | December 18, 1995 | 0 | 1 | 0 | api.fda.gov |
| Ortho-Clinical Diagnostics, Inc. | Rochester, NY, United States | Manufacturer | 1 | December 18, 1995 | 0 | 0 | 0 | api.fda.gov |
| Roche Diagnostics GMBH | MANNHEIM Baden-Wurttemberg, Germany | Exporter to the US, Manufacturer, Repackager or relabeler, Specification developer | 1 | December 23, 2011 | 0 | 0 | 0 | api.fda.gov |
| Beckman Coulter, Inc. | Carlsbad, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| EKF Life Sciences | South Bend, IN, United States | Contract manufacturer | 0 | 0 | 0 | 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 | |
| Stanbio Laboratory | Boerne, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated July 24, 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.