Bio-Chem Laboratory Systems, Inc.
United StatesFDA applicant, unverified
- Devices
- 5
What Bio-Chem Laboratory Systems, Inc. makes
Bio-Chem Laboratory Systems, Inc. manufactures laboratory equipment and diagnostic test kits, including the AUTOBEAD THYROID UPTAKE, AUTOBEAD T4 ENZYME IMMUNOASSAY TEST KIT, AUTOBEAD TSH ENZYME IMMUNOASSAY REAGENT KIT, ATAC 8000 RANDOM ACCESS CHEMISTRY SYSTEM, and ATAC 6000 CHEMISTRY ANALYZER.
The company's products are listed in the FDA 510(k) registry and include Class I and Class II devices. Bio-Chem Laboratory Systems, Inc. is based in the US.
Catalogue
Autobead Thyroid Uptake Ref K930689
Regimes: 510(k) Registry: 510(k)Autobead(Tm) T4 Enzyme Immunoassay Test Kit Ref K926563
Regimes: 510(k) Registry: 510(k)Autobead Tsh Enzyme Immunoassay Reagent Kit Ref K930006
Regimes: 510(k) Registry: 510(k)Atac 8000 Random Access Chemistry System Ref K945271
Regimes: 510(k) Registry: 510(k)Atac 6000 Chemistry Analyzer Ref K924084
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Bio-Chem Laboratory Systems, Inc. have in the registry?
The registry currently lists 5 devices for Bio-Chem Laboratory Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bio-Chem Laboratory Systems, Inc.'s devices?
Among its 5 most recently registered devices, Bio-Chem Laboratory Systems, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Bio-Chem Laboratory Systems, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Bio-Chem Laboratory Systems, Inc.'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 Laboratory Systems, Inc. in the registry?
The most recently registered devices listed for Bio-Chem Laboratory Systems, Inc. include AUTOBEAD THYROID UPTAKE, AUTOBEAD(TM) T4 ENZYME IMMUNOASSAY TEST KIT, AUTOBEAD TSH ENZYME IMMUNOASSAY REAGENT KIT and ATAC 8000 RANDOM ACCESS CHEMISTRY SYSTEM.