Larken Industries, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Larken Industries, Inc. makes
Larken Industries, Inc. manufactures blood glucose monitoring devices, including the GLUCOCHEK III meter and its associated test strips, as well as the STRIP SPLITTER II for strip preparation. The GLUCOCHEK S.C. with an audio option provides audible feedback for users, supporting self-monitoring of blood glucose levels.
The company’s portfolio includes devices classified under FDA’s Class I and Class II categories, with regulatory submissions recorded in the FDA’s 510(k) clearance database. These products are intended for use in the United States.
Catalogue
Glucochek Iii Ref K842474
Regimes: 510(k) Registry: 510(k)Strip Splitter Ii -Half Width Carrier Ref K834150
Regimes: 510(k) Registry: 510(k)Glucochek S.C. With Audio Option Ref K871586
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Larken Industries, Inc. have in the registry?
The registry currently lists 3 devices for Larken Industries, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Larken Industries, Inc.'s devices?
Among its 3 most recently registered devices, Larken Industries, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Larken Industries, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Larken Industries, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Larken Industries, Inc. in the registry?
The most recently registered devices listed for Larken Industries, Inc. include GLUCOCHEK III, STRIP SPLITTER II -HALF WIDTH CARRIER and GLUCOCHEK S.C. WITH AUDIO OPTION.