General Atomics
Country not established
- Devices
- 6
What General Atomics makes
General Atomics manufactures in vitro diagnostic reagents and assay kits, including enzymatic assays for apolipoprotein A-1, homocysteine, LDL-cholesterol, lipoprotein(a), HbA1c, and lithium.
These devices are classified as Class I and Class II medical devices and are listed in the FDA 510(k) registry; the company is based in the United States.
Catalogue
Diazyme Apolipoprotein A-1 Assay Ref K072977
Regimes: 510(k) Registry: 510(k)Diazyme Homocysteine Enzymatic Assay Kit Ref K042448
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Diazyme LP(A) Assay Ref K082488
Regimes: 510(k) Registry: 510(k)HBA1C Enzymatic Assay Ref K050178
Regimes: 510(k) Registry: 510(k)Diazyme Lithium Enzymatic Assay Kit Ref K033360
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does General Atomics have in the registry?
The registry currently lists 6 devices for General Atomics. Devices recorded under merged duplicate company entries are counted once.
Which registries list General Atomics's devices?
Among its 6 most recently registered devices, General Atomics has devices listed in FDA 510(k) (6 devices).
What risk classes do General Atomics's devices fall under?
Among its 6 most recently registered devices, the classes recorded for General Atomics's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from General Atomics in the registry?
The most recently registered devices listed for General Atomics include DIAZYME APOLIPOPROTEIN A-1 ASSAY, DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT, DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLS and DIAZYME LP(A) ASSAY.