Kaulson Laboratories, Inc.
United StatesFDA applicant, unverified
- Devices
- 4
What Kaulson Laboratories, Inc. makes
Kaulson Laboratories, Inc. manufactures laboratory controls for toxicology testing, including heavy metals, drugs, and protoporphyrin measurements. These products are designed to validate and monitor the performance of analytical systems used in clinical and research settings.
The company’s portfolio consists of Class I devices, regulated under the FDA’s 510(k) clearance pathway. These controls are listed in the FDA’s 510(k) database, ensuring compliance with U.S. regulatory standards. The manufacturer is based in the United States.
Catalogue
Contox Heavymetals Control Ref K830234
Regimes: 510(k) Registry: 510(k)Contox Drug Screen Control Ref K830494
Regimes: 510(k) Registry: 510(k)Contox Durg Control Ref K830492
Regimes: 510(k) Registry: 510(k)Protoporphyrin Zn Control Ref K830493
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Kaulson Laboratories, Inc. have in the registry?
The registry currently lists 4 devices for Kaulson Laboratories, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Kaulson Laboratories, Inc.'s devices?
Among its 4 most recently registered devices, Kaulson Laboratories, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Kaulson Laboratories, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Kaulson Laboratories, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Kaulson Laboratories, Inc. in the registry?
The most recently registered devices listed for Kaulson Laboratories, Inc. include CONTOX HEAVYMETALS CONTROL, CONTOX DRUG SCREEN CONTROL, CONTOX DURG CONTROL and PROTOPORPHYRIN ZN CONTROL.