Bio-Chem Laboratories
Country not established
- Devices
- 2
What Bio-Chem Laboratories makes
Bio-Chem Laboratories manufactures the HEMOTECT, a device for detecting occult blood in stool samples, and the ATAC 6000 CHEMISTRY ANALYZER, an automated chemistry analyzer for clinical laboratory testing.
The company’s portfolio includes Class I and Class II devices, all of which are listed under the FDA’s 510(k) pathway. The manufacturer is based in the United States.
Catalogue
Hemotect Ref K822731
Regimes: 510(k) Registry: 510(k)Atac 6000 Chemistry Analyzer Ref K902689
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Bio-Chem Laboratories have in the registry?
The registry currently lists 2 devices for Bio-Chem Laboratories. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bio-Chem Laboratories's devices?
Among its 2 most recently registered devices, Bio-Chem Laboratories has devices listed in FDA 510(k) (2 devices).
What risk classes do Bio-Chem Laboratories's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Bio-Chem Laboratories's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Bio-Chem Laboratories in the registry?
The most recently registered devices listed for Bio-Chem Laboratories include HEMOTECT and ATAC 6000 CHEMISTRY ANALYZER.