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Data / Medical devices / Alkaline Picrate, Colorimetry, Creatinine / United States

FDA-registered makers of Alkaline Picrate, Colorimetry, Creatinine in the United States: 22 establishments

22 establishments in the United States are registered with the FDA to make Alkaline Picrate, Colorimetry, Creatinine (product code CGX). 15 have a 510(k) clearance or PMA approval on file and 4 have a recall event. FDA data exported November 3, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

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Device
Alkaline Picrate, Colorimetry, Creatinine
Product code
CGX
Country
United States

Makers of Alkaline Picrate, Colorimetry, Creatinine in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Beckman Coulter, Inc.Brea, CA, United StatesManufacturer, Specification developer3June 1, 2007020api.fda.gov
Siemens Healthcare Diagnostics Inc.Newark, DE, United StatesManufacturer, Specification developer3December 4, 2024030api.fda.gov
SCITECK DiagnosticsFletcher, NC, United StatesManufacturer2March 6, 1997000api.fda.gov
Siemens Healthcare Diagnostics Inc.Tarrytown, NY, United StatesComplaint file establishment, Specification developer2December 4, 2024010api.fda.gov
Abbott LaboratoriesIrving, TX, United StatesSpecification developer1April 7, 2009000api.fda.gov
Bialex LabWichita Falls, TX, United StatesManufacturer1May 15, 2013000api.fda.gov
Cliniqa CorporationSan Marcos, CA, United StatesManufacturer1April 18, 1984000api.fda.gov
Carolina Liquid ChemistriesBrea, CA, United StatesManufacturer1December 27, 2004000api.fda.gov
DIAMOND DIAGNOSTICS IncHolliston, MA, United StatesManufacturer1January 30, 2004000api.fda.gov
Horiba Instruments IncorporatedCanton, MI, United StatesManufacturer1March 24, 1983020api.fda.gov
Infrared Laboratory Systems dba SYNERMEDWestfield, IN, United StatesManufacturer1February 24, 1998000api.fda.gov
Medica Corp.Bedford, MA, United StatesManufacturer1May 15, 2013000api.fda.gov
Nova Biomedical CorporationWaltham, MA, United StatesComplaint file establishment, Manufacturer1November 19, 2024000api.fda.gov
Stanbio LaboratoryBoerne, TX, United StatesManufacturer1November 3, 1977000api.fda.gov
Teco DiagnosticsAnaheim, CA, United StatesManufacturer1March 23, 1988000api.fda.gov
Abaxis, Inc.Union City, CA, United StatesManufacturer0000api.fda.gov
Alfa WassermannWest Caldwell, NJ, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
Beckman Coulter, Inc.Carlsbad, CA, United StatesContract manufacturer0000api.fda.gov
Depuy Orthopaedics, Inc.Warsaw, IN, United StatesSpecification developer0000api.fda.gov
Fisher DiagnosticsMiddletown, VA, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Nova Biomedical CorporationBillerica, MA, United StatesManufacturer for export0000api.fda.gov
Siemens Healthcare Diagnostics IncEast Walpole, MA, United StatesSpecification developer0000api.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.