Data / Medical devices / China / Beckman Coulter Laboratory Systems (suzhou) Co., Ltd.
Beckman Coulter Laboratory Systems (suzhou) Co., Ltd.: FDA-registered device maker in Suzhou Jiangsu, China, 1 510(k) clearance
Beckman Coulter Laboratory Systems (suzhou) Co., Ltd. is registered with the FDA (registration 3027977508) in Suzhou Jiangsu, China. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 20, 2023. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3027977508
- Address
- No.11, Zhensheng Road, Suzhou Industrial Park Area 1, 1st Floor, Building 4; Area 1, Building 3; Area 1, Building 2, Suzhou Jiangsu, China, 215126
- Owner or operator
- BECKMAN COULTER, INC. (2050012)
- Roles
- Contract manufacturer, Manufacturer, Specification developer
- First device listed
- April 28, 1999
- Registered through
- 2026
- Brand names listed
- A15445 IMMAGE 800, Access C-Peptide (P/N: C33451), Access C-Peptide Calibrators (P/N: C31860), Access Sensitive Estradiol Calibrator S0 (P/N: B97145), Access Sensitive Estradiol Calibrators (P/N: B84494), Access Syphilis Calibrators (P/N: C80412 MFG-BioRad), DxC 500 AU Clinical Chemistry Analyzer
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | 1 | Contract manufacturer, Specification developer | accessdata.fda.gov |
| Calibrator, Secondary | JIT | 2 | Manufacturer | accessdata.fda.gov |
| Nephelometer, For Clinical Use | JQX | 1 | Contract manufacturer | accessdata.fda.gov |
| Radioimmunoassay, C-Peptides Of Proinsulin | JKD | 1 | 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 |
|---|---|---|---|---|---|---|
| July 20, 2023 | K220977 | ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer | JGS | Substantially Equivalent | Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| January 10, 2025 | 96193 | Class II | Ongoing | DxC 500 AU Clinical Chemistry Analyzer, REF: C63519, and C63520 with affected software. | Beckman Coulter has identified an issue which prevents the DxC 500 AU instrument from providing the correct onboard stability (Open Expiration) dates for assays that were loaded prior to a software upgrade (e.g. 1.3 to 1.4, 1.4 to 1.4.1, etc.). As a result, assays that have expired may still be used for sample processing, leading to inaccurate or erroneous p | accessdata.fda.gov |
Compare with other makers
- All makers of Calibrator, Secondary
- All makers of Radioimmunoassay, C-Peptides Of Proinsulin
- All makers of Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- All makers of Nephelometer, For Clinical Use
Updated February 25, 2025. 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.