Lkb Instruments, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 52
What Lkb Instruments, Inc. makes
LKB Instruments, Inc. manufactures ultraviolet and visible spectrophotometry systems, including the Ultrospec series and Novaspec, used for measuring light absorption in biochemical and clinical applications. The company also produces immunoassay kits under the Delfia™ brand, including tests for thyroxine (T4), ferritin, human chorionic gonadotropin (HCG), and other biomarkers. Additional products include specialized metabolic analysis tools, such as the Engstrom Metabolic Computer, and a gamma counter for radioactive sample analysis.
The company’s devices are classified under FDA’s Class I and Class II categories, with relevant products listed via the 510(k) pathway. These instruments and kits are intended for in vitro diagnostic use and are regulated under the U.S. Food and Drug Administration’s medical device authorities. LKB Instruments, Inc. is based in the United States.
Catalogue
Search and filter all 52 devicesShowing 1-50 of 52
Frequently asked questions
How many devices does Lkb Instruments, Inc. have in the registry?
The registry currently lists 52 devices for Lkb Instruments, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Lkb Instruments, Inc.'s devices?
Among its 50 most recently registered devices, Lkb Instruments, Inc. has devices listed in FDA 510(k) (50 devices).
What risk classes do Lkb Instruments, Inc.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Lkb Instruments, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Lkb Instruments, Inc. in the registry?
The most recently registered devices listed for Lkb Instruments, Inc. include ULTROSPEC W/APPLE II -4050-, ULTROSPEC K KINETICS SPECTROPHOTOMETER, ENGSTOM EDITH and DELFIA(TM) THYROXINE (T4) KIT.