Bacton Assay Systems, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Bacton Assay Systems, Inc. makes
Bacton Assay Systems, Inc. manufactures diagnostic reagents for automated blood analysis, including the BACTON™ AUTO-APO B REAGENT and BACTON™ AUTO-APO A-1 REAGENT, which are used in laboratory testing for blood components like apolipoproteins.
These reagents are classified as Class I medical devices under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Bacton(Tm), Auto-Apo B Reagent Ref K921862
Regimes: 510(k) Registry: 510(k)Bacton(Tm), Auto-Apo A-1 Reagent Ref K921795
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Bacton Assay Systems, Inc. have in the registry?
The registry currently lists 2 devices for Bacton Assay Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bacton Assay Systems, Inc.'s devices?
Among its 2 most recently registered devices, Bacton Assay Systems, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Bacton Assay Systems, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Bacton Assay Systems, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Bacton Assay Systems, Inc. in the registry?
The most recently registered devices listed for Bacton Assay Systems, Inc. include BACTON(TM), AUTO-APO B REAGENT and BACTON(TM), AUTO-APO A-1 REAGENT.