Data / Medical devices / Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis
Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis (PER): 11 FDA-registered makers in 5 countries
11 establishments in 5 countries are registered with the FDA to make Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis (product code PER, Class 1, 21 CFR 862.2750). 2 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 3 510(k) clearances under this code, the latest on August 2, 2013, and lists 7 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- PER
- Device class
- 1
- Regulation
- 862.2750
- Medical specialty
- Clinical Chemistry
Makers by country
| Country | Makers |
|---|---|
| United States | 7 |
| Taiwan | 1 |
| Germany | 1 |
| Switzerland | 1 |
| Japan | 1 |
Makers of Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis
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 |
|---|---|---|---|---|---|---|---|---|
| Becton, Dickinson and Company, BD Biosciences | Milpitas, CA, United States | Complaint file establishment, Specification developer | 2 | August 2, 2013 | 0 | 1 | 0 | api.fda.gov |
| Beckman Coulter, Inc. | Miami, FL, United States | Manufacturer | 1 | July 15, 2013 | 0 | 2 | 0 | api.fda.gov |
| Bloodscan Biotech Inc. | Nangang Dist. Taipei, Taiwan | Complaint file establishment, Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| One Lambda, Inc. | West Hills, CA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stratec Se | BIRKENFELD, GRAEFENHAUSEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| STRATEC Switzerland AG | Beringen Schaffhausen, Switzerland | Contract 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 | |
| Sysmex Corporation Techno Park | KOBE Hyogo, Japan | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sysmex America, Inc. | Buffalo Grove, IL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sysmex America, Inc. - Vernon Hills | Vernon Hills, IL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tecan Cdmo Solutions MH, Corp. | Morgan Hill, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated August 2, 2013. 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.