Data / Medical devices / Controls For Blood-Gases, (Assayed And Unassayed) / United States
FDA-registered makers of Controls For Blood-Gases, (Assayed And Unassayed) in the United States: 9 establishments
9 establishments in the United States are registered with the FDA to make Controls For Blood-Gases, (Assayed And Unassayed) (product code JJS). 7 have a 510(k) clearance or PMA approval on file and 0 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.
- Device
- Controls For Blood-Gases, (Assayed And Unassayed)
- Product code
- JJS
- Country
- United States
Makers of Controls For Blood-Gases, (Assayed And Unassayed) in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Bio-Rad Laboratories Inc. | Irvine, CA, United States | Specification developer | 6 | August 15, 2002 | 0 | 0 | 0 | api.fda.gov |
| Bio-Rad Laboratories Inc. | Irvine, CA, United States | Specification developer | 6 | August 15, 2002 | 0 | 0 | 0 | api.fda.gov |
| Bionostics, Inc. | Devens, MA, United States | Contract manufacturer, Manufacturer | 2 | August 30, 2000 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | Tarrytown, NY, United States | Complaint file establishment, Specification developer | 2 | January 30, 1995 | 0 | 0 | 0 | api.fda.gov |
| DIAMOND DIAGNOSTICS Inc | Holliston, MA, United States | Manufacturer | 1 | December 12, 2003 | 0 | 0 | 0 | api.fda.gov |
| Phoenix Diagnostics, Inc. | Natick, MA, United States | Manufacturer | 1 | July 14, 1992 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc | East Walpole, MA, United States | Specification developer | 1 | January 14, 1987 | 0 | 0 | 0 | api.fda.gov |
| Nova Biomedical Corporation | Waltham, MA, United States | Complaint file establishment, 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 |
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.