Data / Medical devices / Calibrator, Surrogate
Calibrator, Surrogate (JIW): 5 FDA-registered makers in 4 countries
5 establishments in 4 countries are registered with the FDA to make Calibrator, Surrogate (product code JIW, Class 2, 21 CFR 862.1150). 1 of them has a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 17 510(k) clearances under this code, the latest on September 25, 1997, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- JIW
- Device class
- 2
- Regulation
- 862.1150
- Medical specialty
- Clinical Chemistry
Makers by country
| Country | Makers |
|---|---|
| Japan | 2 |
| United States | 1 |
| Philippines | 1 |
| United Kingdom | 1 |
Makers of Calibrator, Surrogate
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 |
|---|---|---|---|---|---|---|---|---|
| Siemens Healthcare Diagnostics Inc. | Newark, DE, United States | Manufacturer | 1 | February 20, 1997 | 0 | 0 | 0 | api.fda.gov |
| Arkray Industry Inc. | Sto. Tomas Batangas, Philippines | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Benson Viscometers Ltd | Haverfordwest Pembrokeshire, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sysmex Corporation Seishin Factory | Kobe Hyogo, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sysmex Corporation Techno Park | KOBE Hyogo, Japan | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated September 25, 1997. 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.