Beckman
Country not established
- Devices
- 5
What Beckman makes
Beckman manufactures reagent modifications and kits for immunoassay analyzers, including a cholineesterase reagent kit and a P-amylase control. Their portfolio also includes clinical chemistry analyzers, such as the SYNCHRON CX 7 and SYNCHRON CX4-CE, designed for laboratory testing of blood and other biological samples.
These devices are regulated under FDA 510(k) clearance, with classifications spanning Class I and Class II. The company’s products are listed in the FDA’s 510(k) registry, and the manufacturer is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Beckman Cholinesterase Reagent Kit Ref K893583
Regimes: 510(k) Registry: 510(k)P-Amylase Control Ref K935362
Regimes: 510(k) Registry: 510(k)Synchron Cx 7 Clinical Analyzer Ref K904219
Regimes: 510(k) Registry: 510(k)Synchron CX4-Ce Ref K904220
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Beckman have in the registry?
The registry currently lists 5 devices for Beckman. Devices recorded under merged duplicate company entries are counted once.
Which registries list Beckman's devices?
Among its 5 most recently registered devices, Beckman has devices listed in FDA 510(k) (5 devices).
What risk classes do Beckman's devices fall under?
Among its 5 most recently registered devices, the classes recorded for Beckman's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Beckman in the registry?
The most recently registered devices listed for Beckman include MODIFICATION TO ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33200, 33205, 33209, 33206, BECKMAN CHOLINESTERASE REAGENT KIT, P-AMYLASE CONTROL and SYNCHRON CX 7 CLINICAL ANALYZER.