Fairlake Laboratories
Country not established
- Devices
- 2
What Fairlake Laboratories makes
Fairlake Laboratories manufactures single-reagent radioimmunoassay (RIA) kits for thyroid hormone testing, including T3-RIA and T4-RIA reagents. These products are designed for in vitro diagnostic use to measure triiodothyronine (T3) and thyroxine (T4) levels in serum or plasma samples.
The company’s portfolio is regulated under FDA’s Class II device classification and is listed via the 510(k) premarket notification process. The products are intended for use in the United States.
Catalogue
T3-Ria Single Reagent Ref K832469
Regimes: 510(k) Registry: 510(k)T4-Ria Single Reagent Ref K832468
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Fairlake Laboratories have in the registry?
The registry currently lists 2 devices for Fairlake Laboratories. Devices recorded under merged duplicate company entries are counted once.
Which registries list Fairlake Laboratories's devices?
Among its 2 most recently registered devices, Fairlake Laboratories has devices listed in FDA 510(k) (2 devices).
What risk classes do Fairlake Laboratories's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Fairlake Laboratories's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Fairlake Laboratories in the registry?
The most recently registered devices listed for Fairlake Laboratories include T3-RIA SINGLE REAGENT and T4-RIA SINGLE REAGENT.