Data / Medical devices / India / Beckman Coulter India Private Limited
Beckman Coulter India Private Limited: FDA-registered device maker in Bengaluru (Bangalore) Urban Karnataka, India, 2 510(k) clearances
Beckman Coulter India Private Limited is registered with the FDA (registration 3016954941) in Bengaluru (Bangalore) Urban Karnataka, India. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated November 22, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016954941
- Address
- Plot No 37/1 Hitech/Defence Aerospace IT Sector Mahadevakodigehalli Village, Hobli Jala Taluk, Bangalore North, Bengaluru (Bangalore) Urban Karnataka, India, 562149
- Owner or operator
- BECKMAN COULTER, INC. (2050012)
- Roles
- Contract manufacturer, Manufacturer, Specification developer
- First device listed
- February 11, 2005
- Registered through
- 2026
- Brand names listed
- 442831 PVT 2, 472055 PVT 5, 442830 PVT 3, 445865 SYNCHRON Systems Wash Concentrate II, 445967 SYNCHRON CX Systems Antifoam, 447040 IMMAGE Immunochemistry Systems BUF 2 Buffer 2, 447050 IMMAGE Immunochemistry Systems BUF 3 Buffer 3, 447060 IMMAGE Immunochemistry Systems Wash Solution, 447420 IMMAGE Immunochemistry Systems BUF 4 Buffer 4, 447640 IMMAGE Immunochemistry Systems DIL 1 Diluent 1 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Flow Cytometric Reagents And Accessories. | OYE | 2 | Manufacturer | accessdata.fda.gov |
| Flow Cytometric Test System For Hematopoietic Neoplasms | PWD | 2 | Manufacturer | accessdata.fda.gov |
| General Purpose Reagent | PPM | 1 | Specification developer | accessdata.fda.gov |
| Reagents, Specific, Analyte | MVU | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 22, 2023 | K232600 | DxFLEX Flow Cytometer; ClearLLab 10C Panels | OYE | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| March 21, 2019 | K183592 | ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios EX Flow Cytometer | PWD | Substantially Equivalent | Beckman Coulter | accessdata.fda.gov |
Compare with other makers
- All makers of General Purpose Reagent
- All makers of Reagents, Specific, Analyte
- All makers of Flow Cytometric Test System For Hematopoietic Neoplasms
- All makers of Flow Cytometric Reagents And Accessories.
Updated November 22, 2023. 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.