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
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Siemens Healthcare Diagnostics Inc. | Newark, DE, United States | Complaint file establishment, Manufacturer, Specification developer | 7 | March 22, 2013 | 0 | 38 | 0 | api.fda.gov |
| Scientific Supplies & Technology, Inc. | Doral, FL, United States | Remanufacturer, Repackager or relabeler | 3 | April 8, 1997 | 0 | 0 | 0 | api.fda.gov |
| Ortho-Clinical Diagnostics, Inc. | Rochester, NY, United States | Complaint file establishment, Specification developer | 2 | January 17, 1995 | 0 | 50 | 0 | api.fda.gov |
| Stanbio Laboratory | Boerne, TX, United States | Manufacturer, Repackager or relabeler, Specification developer | 2 | March 14, 2005 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | Tarrytown, NY, United States | Complaint file establishment, Specification developer | 2 | April 8, 1997 | 0 | 18 | 0 | api.fda.gov |
| Teco Diagnostics | Anaheim, CA, United States | Manufacturer, Repackager or relabeler | 2 | May 8, 2008 | 0 | 0 | 0 | api.fda.gov |
| Alfa Wassermann | West Caldwell, NJ, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 1 | May 17, 2012 | 0 | 0 | 0 | api.fda.gov |
| Beckman Coulter, Inc. | Brea, CA, United States | Manufacturer, Specification developer | 1 | March 10, 1997 | 0 | 62 | 0 | api.fda.gov |
| Beckman Coulter, Inc. | Chaska, MN, United States | Manufacturer | 1 | January 28, 2003 | 0 | 25 | 0 | api.fda.gov |
| Carolina Liquid Chemistries | Brea, CA, United States | Complaint file establishment, Specification developer | 1 | May 16, 2014 | 0 | 0 | 0 | api.fda.gov |
| Fisher Diagnostics | Middletown, VA, United States | Contract manufacturer, Manufacturer, Manufacturer for export | 1 | September 21, 1993 | 0 | 0 | 0 | api.fda.gov |
| Ortho-Clinical Diagnostics, Inc. | Rochester, NY, United States | Manufacturer | 1 | January 17, 1995 | 0 | 1 | 0 | api.fda.gov |
| Sanzay Corporation - | Miami Gardens, FL, United States | Remanufacturer, Repackager or relabeler | 1 | May 15, 2014 | 0 | 0 | 0 | api.fda.gov |
| Abbott Laboratories | Irving, TX, United States | Manufacturer, Specification developer | 0 | 0 | 5 | 0 | api.fda.gov | |
| Abbott Laboratories | Abbott Park, IL, United States | Manufacturer | 0 | 0 | 7 | 0 | api.fda.gov | |
| Abbott Point Of Care Inc. | Princeton, NJ, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Awareness Technology, Inc. | Palm City, FL, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alere San Diego, Inc. | San Diego, CA, United States | Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Beckman Coulter, Inc. | Carlsbad, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bio-Rad Laboratories, Inc. | Hercules, CA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cliniqa Corporation | San Marcos, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Currier Plastics | Auburn, NY, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Carclo Technical Plastics - Latrobe | Latrobe, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Classic Industries, Inc. | Latrobe, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DIAMOND DIAGNOSTICS Inc | Holliston, MA, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Diasorin Inc. | Stillwater, MN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Diazyme Laboratories, Inc. | Poway, CA, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ELITechGroup Inc | Logan, UT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Epitope Diagnostics, Inc. | San Diego, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fujirebio Diagnostics, Inc. | Seguin, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gold Standard Diagnostics, LLC | Davis, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hamilton Co. | Reno, NV, United States | Contract manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Healgen Scientific LLC | Houston, TX, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hycor Biomedical | Garden Grove, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| High Technology, Inc. | North Attleboro, MA, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Inova Diagnostics, Inc. | San Diego, CA, United States | Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Instrumentation Laboratory Co. | Bedford, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Instrumentation Laboratory Co. | Orangeburg, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Infrared Laboratory Systems dba SYNERMED | Westfield, IN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| LMSI, LLC dba Lighthouse Lab Services | Carrollton, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medica Corp. | Bedford, MA, United States | Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| MGS Germantown A Division Of MGS Group NA Inc | Germantown, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Monobind, Inc. | Lake Forest, CA, United States | Manufacturer, Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nova Biomedical Corporation | Waltham, MA, United States | Complaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export, Remanufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nova Biomedical Corporation | Billerica, MA, United States | Manufacturer, Manufacturer for export, Remanufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nypro Inc. (Chicago) | Gurnee, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Opti Medical Systems Inc. | Roswell, GA, United States | Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Ortho-Clinical Diagnostics, Inc. | Rochester, NY, United States | Manufacturer | 0 | 0 | 2 | 0 | api.fda.gov | |
| Sequitur Health Corp. | Phoenix, AZ, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| STS Corporation | Duluth, GA, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Siemens Healthcare Diagnostics Inc. | E Walpole, MA, United States | Manufacturer | 0 | 0 | 3 | 0 | api.fda.gov | |
| Tessy Plastics Corp. | Elbridge, NY, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| TN Michigan, LLC | Sault Sainte Marie, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Trinity Biotech (Primus Corporation dba Trinity Biotech) | Kansas City, MO, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Westfall Technik Chicago | Antioch, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.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.