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Data / Medical devices / Cresolphthalein Complexone, Calcium

Cresolphthalein Complexone, Calcium (CIC): 17 FDA-registered makers in 7 countries

17 establishments in 7 countries are registered with the FDA to make Cresolphthalein Complexone, Calcium (product code CIC, Class 2, 21 CFR 862.1145). 9 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 99 510(k) clearances under this code, the latest on May 2, 2013, and lists 7 recall events (0 Class I). FDA data exported November 2, 2026.

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Get every maker of this deviceMakers in the United StatesWatch this device
Product code
CIC
Device class
2
Regulation
862.1145
Medical specialty
Clinical Chemistry

Makers by country

CountryMakers
United States9
Japan2
Germany2
France1
United Kingdom1
Argentina1
Switzerland1

Makers of Cresolphthalein Complexone, Calcium

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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Fisher DiagnosticsMiddletown, VA, United StatesManufacturer3September 13, 1990000api.fda.gov
Horiba Instruments IncorporatedCanton, MI, United StatesManufacturer2May 13, 1992010api.fda.gov
Cliniqa CorporationSan Marcos, CA, United StatesManufacturer1June 25, 2004000api.fda.gov
Hemagen Diagnostics, Inc.Baltimore, MD, United StatesManufacturer1July 29, 1986000api.fda.gov
Horiba Abx SASMONTPELLIER Herault, FranceManufacturer, Specification developer1April 26, 2007000api.fda.gov
Infrared Laboratory Systems dba SYNERMEDWestfield, IN, United StatesManufacturer1October 4, 1990000api.fda.gov
Randox Laboratories LimitedCRUMLIN, COUNTY ANTRIM Antrim and Newtownabbey, United KingdomContract manufacturer, Manufacturer1April 5, 2000000api.fda.gov
Teco DiagnosticsAnaheim, CA, United StatesManufacturer1January 9, 1987000api.fda.gov
Wiener Laboratorios S.A.I.C.ROSARIO Santa Fe, ArgentinaManufacturer1December 21, 2001000api.fda.gov
Beckman Coulter K. K.Sunto-Gun Shizuoka, JapanSpecification developer0000api.fda.gov
Beckman Coulter Mishima K.K.SUNTO-GUN Shizuoka, JapanContract manufacturer0000api.fda.gov
High Technology, Inc.North Attleboro, MA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Roche Diagnostics GMBHMANNHEIM Baden-Wurttemberg, GermanyExporter to the US, Manufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Roche Diagnostics GMBHPENZBERG Bavaria, GermanyManufacturer0000api.fda.gov
Roche Diagnostics International Ltd.ROTKREUZ Zug, SwitzerlandManufacturer0000api.fda.gov
Siemens Healthcare Diagnostics Inc.Newark, DE, United StatesManufacturer, Specification developer0020api.fda.gov
Siemens Healthcare Diagnostics Inc.Tarrytown, NY, United StatesComplaint file establishment, Specification developer0000api.fda.gov

Updated May 2, 2013. 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.