Data / Medical devices / Device, Automated Sedimentation Rate
Device, Automated Sedimentation Rate (GKB): 16 FDA-registered makers in 6 countries
16 establishments in 6 countries are registered with the FDA to make Device, Automated Sedimentation Rate (product code GKB, Class 1, 21 CFR 864.5800). 0 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 2 510(k) clearances under this code, the latest on May 24, 1989, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- GKB
- Device class
- 1
- Regulation
- 864.5800
- Medical specialty
- Hematology
Makers by country
| Country | Makers |
|---|---|
| United States | 5 |
| China | 4 |
| Italy | 3 |
| India | 2 |
| Netherlands | 1 |
| Germany | 1 |
Makers of Device, Automated Sedimentation Rate
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 |
|---|---|---|---|---|---|---|---|---|
| Alcor Scientific LLC | Smithfield, RI, United States | Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Alifax SRL | Nimis Udine, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| AirScan, Inc. | Annandale, NJ, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biobase Biodustry(shandong)co., Ltd | Jinan Shandong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Diesse Diagnostica Senese S.P.A | MONTERIGGIONI Siena, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ELITechGroup Inc | Logan, UT, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Labpeak Co.,ltd | Jinan Shandong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| LP Italiana SPA | MILAN Milano, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| RR MECHATRONICS Manufacturing B.V. | ZWAAG Noord-Holland, Netherlands | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sarstedt AG & Co. KG | NUMBRECHT North Rhine-Westphalia, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Scitek Global Co.,ltd | Jinan Shandong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Yhlo Biotech Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sterile Safequip & Chemicals Limited | Ahmedabad Gujarat, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Strumed Solutions Private Limited | Surat Gujarat, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sysmex America, Inc. | Buffalo Grove, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sysmex America, Inc. - Vernon Hills | Vernon Hills, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated May 24, 1989. 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.