American Biological Technologies, Inc.
United StatesFDA applicant, unverified
- Devices
- 4
What American Biological Technologies, Inc. makes
American Biological Technologies, Inc. manufactures glucose control solutions designed for testing and calibration of blood glucose monitoring systems. These include standard and tiered-level solutions (Level 1, 2, and 3) to simulate varying glucose concentrations for accuracy verification.
The company’s products are classified as Class I medical devices under FDA regulations and are listed via 510(k) clearance. The manufacturer is based in the United States.
Catalogue
Abt Glucose Control Solution, Model: 2120089 Ref K090943
Regimes: 510(k) Registry: 510(k)Abt Glucose Control Solution Ref K083549
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Abt Glucose Control Solution, Model 2120090 Ref K090854
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does American Biological Technologies, Inc. have in the registry?
The registry currently lists 4 devices for American Biological Technologies, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list American Biological Technologies, Inc.'s devices?
Among its 4 most recently registered devices, American Biological Technologies, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do American Biological Technologies, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for American Biological Technologies, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from American Biological Technologies, Inc. in the registry?
The most recently registered devices listed for American Biological Technologies, Inc. include ABT GLUCOSE CONTROL SOLUTION, MODEL: 2120089, ABT GLUCOSE CONTROL SOLUTION, ABT GLUCOSE CONTROL SOLUTION LEVEL 1, 2, 3 MODEL, 2120083, 2120086, 2120087 and ABT GLUCOSE CONTROL SOLUTION, MODEL 2120090.