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Data / Medical devices / Analyzer, Chemistry (Photometric, Discrete), For Clinical Use / United States

FDA-registered makers of Analyzer, Chemistry (Photometric, Discrete), For Clinical Use in the United States: 55 establishments

55 establishments in the United States are registered with the FDA to make Analyzer, Chemistry (Photometric, Discrete), For Clinical Use (product code JJE). 13 have a 510(k) clearance or PMA approval on file and 15 have a recall event. FDA data exported November 3, 2026.

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Device
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Product code
JJE
Country
United States

Makers of Analyzer, Chemistry (Photometric, Discrete), For Clinical Use in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Siemens Healthcare Diagnostics Inc.Newark, DE, United StatesComplaint file establishment, Manufacturer, Specification developer7March 22, 20130380api.fda.gov
Scientific Supplies & Technology, Inc.Doral, FL, United StatesRemanufacturer, Repackager or relabeler3April 8, 1997000api.fda.gov
Ortho-Clinical Diagnostics, Inc.Rochester, NY, United StatesComplaint file establishment, Specification developer2January 17, 19950500api.fda.gov
Stanbio LaboratoryBoerne, TX, United StatesManufacturer, Repackager or relabeler, Specification developer2March 14, 2005000api.fda.gov
Siemens Healthcare Diagnostics Inc.Tarrytown, NY, United StatesComplaint file establishment, Specification developer2April 8, 19970180api.fda.gov
Teco DiagnosticsAnaheim, CA, United StatesManufacturer, Repackager or relabeler2May 8, 2008000api.fda.gov
Alfa WassermannWest Caldwell, NJ, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer1May 17, 2012000api.fda.gov
Beckman Coulter, Inc.Brea, CA, United StatesManufacturer, Specification developer1March 10, 19970620api.fda.gov
Beckman Coulter, Inc.Chaska, MN, United StatesManufacturer1January 28, 20030250api.fda.gov
Carolina Liquid ChemistriesBrea, CA, United StatesComplaint file establishment, Specification developer1May 16, 2014000api.fda.gov
Fisher DiagnosticsMiddletown, VA, United StatesContract manufacturer, Manufacturer, Manufacturer for export1September 21, 1993000api.fda.gov
Ortho-Clinical Diagnostics, Inc.Rochester, NY, United StatesManufacturer1January 17, 1995010api.fda.gov
Sanzay Corporation -Miami Gardens, FL, United StatesRemanufacturer, Repackager or relabeler1May 15, 2014000api.fda.gov
Abbott LaboratoriesIrving, TX, United StatesManufacturer, Specification developer0050api.fda.gov
Abbott LaboratoriesAbbott Park, IL, United StatesManufacturer0070api.fda.gov
Abbott Point Of Care Inc.Princeton, NJ, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Awareness Technology, Inc.Palm City, FL, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Alere San Diego, Inc.San Diego, CA, United StatesManufacturer0010api.fda.gov
Beckman Coulter, Inc.Carlsbad, CA, United StatesContract manufacturer0000api.fda.gov
Bio-Rad Laboratories, Inc.Hercules, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Cliniqa CorporationSan Marcos, CA, United StatesContract manufacturer0000api.fda.gov
Currier PlasticsAuburn, NY, United StatesContract manufacturer0000api.fda.gov
Carclo Technical Plastics - LatrobeLatrobe, PA, United StatesContract manufacturer0000api.fda.gov
Classic Industries, Inc.Latrobe, PA, United StatesContract manufacturer0000api.fda.gov
DIAMOND DIAGNOSTICS IncHolliston, MA, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Diasorin Inc.Stillwater, MN, United StatesManufacturer0000api.fda.gov
Diazyme Laboratories, Inc.Poway, CA, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
ELITechGroup IncLogan, UT, United StatesContract manufacturer0000api.fda.gov
Epitope Diagnostics, Inc.San Diego, CA, United StatesManufacturer0000api.fda.gov
Fujirebio Diagnostics, Inc.Seguin, TX, United StatesManufacturer0000api.fda.gov
Gold Standard Diagnostics, LLCDavis, CA, United StatesManufacturer0000api.fda.gov
Hamilton Co.Reno, NV, United StatesContract manufacturer0010api.fda.gov
Healgen Scientific LLCHouston, TX, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Hycor BiomedicalGarden Grove, CA, United StatesManufacturer0000api.fda.gov
High Technology, Inc.North Attleboro, MA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Inova Diagnostics, Inc.San Diego, CA, United StatesManufacturer0010api.fda.gov
Instrumentation Laboratory Co.Bedford, MA, United StatesManufacturer0000api.fda.gov
Instrumentation Laboratory Co.Orangeburg, NY, United StatesManufacturer0000api.fda.gov
Infrared Laboratory Systems dba SYNERMEDWestfield, IN, United StatesManufacturer0000api.fda.gov
LMSI, LLC dba Lighthouse Lab ServicesCarrollton, TX, United StatesManufacturer0000api.fda.gov
Medica Corp.Bedford, MA, United StatesManufacturer0010api.fda.gov
MGS Germantown A Division Of MGS Group NA IncGermantown, WI, United StatesContract manufacturer0000api.fda.gov
Monobind, Inc.Lake Forest, CA, United StatesManufacturer, Manufacturer for export0000api.fda.gov
Nova Biomedical CorporationWaltham, MA, United StatesComplaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export, Remanufacturer0000api.fda.gov
Nova Biomedical CorporationBillerica, MA, United StatesManufacturer, Manufacturer for export, Remanufacturer0000api.fda.gov
Nypro Inc. (Chicago)Gurnee, IL, United StatesContract manufacturer0000api.fda.gov
Opti Medical Systems Inc.Roswell, GA, United StatesManufacturer0010api.fda.gov
Ortho-Clinical Diagnostics, Inc.Rochester, NY, United StatesManufacturer0020api.fda.gov
Sequitur Health Corp.Phoenix, AZ, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
STS CorporationDuluth, GA, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
Siemens Healthcare Diagnostics Inc.E Walpole, MA, United StatesManufacturer0030api.fda.gov
Tessy Plastics Corp.Elbridge, NY, United StatesContract manufacturer0000api.fda.gov
TN Michigan, LLCSault Sainte Marie, MI, United StatesContract manufacturer0000api.fda.gov
Trinity Biotech (Primus Corporation dba Trinity Biotech)Kansas City, MO, United StatesManufacturer for export0000api.fda.gov
Westfall Technik ChicagoAntioch, IL, United StatesContract manufacturer0000api.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.