Data / Medical devices / Controls For Blood-Gases, (Assayed And Unassayed)
Controls For Blood-Gases, (Assayed And Unassayed) (JJS): 16 FDA-registered makers in 8 countries
16 establishments in 8 countries are registered with the FDA to make Controls For Blood-Gases, (Assayed And Unassayed) (product code JJS, Class 1, 21 CFR 862.1660). 10 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 67 510(k) clearances under this code, the latest on April 22, 2016, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- JJS
- Device class
- 1
- Regulation
- 862.1660
- Medical specialty
- Clinical Chemistry
Makers by country
| Country | Makers |
|---|---|
| United States | 9 |
| Denmark | 1 |
| Poland | 1 |
| Netherlands | 1 |
| Spain | 1 |
| Hungary | 1 |
| China | 1 |
| United Kingdom | 1 |
Makers of Controls For Blood-Gases, (Assayed And Unassayed)
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.
| 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 |
| Radiometer Medical Aps | BROENSHOEJ Hovedstaden, Denmark | Complaint file establishment, Manufacturer | 4 | May 13, 2015 | 0 | 0 | 0 | api.fda.gov |
| Radiometer Solutions Sp. z o.o. | Stargard Zachodniopomorskie, Poland | Complaint file establishment, Contract manufacturer | 3 | May 13, 2015 | 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 |
| Eurotrol B.V. | EDE Gelderland, Netherlands | Manufacturer | 2 | April 22, 2016 | 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 |
| Biokit S.A. | LLISSA D AMUNT Barcelona, Spain | Exporter to the US, Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Diamond Diagnostics Inc. | Budapest, Hungary | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Edan Instruments, Inc. | Shenzhen Guangdong, China | Manufacturer | 0 | 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 | |
| Randox Laboratories Limited | CRUMLIN, COUNTY ANTRIM Antrim and Newtownabbey, United Kingdom | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated April 22, 2016. 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.