Spectrx, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Spectrx, Inc. makes
Spectrx, Inc. manufactures the Bilichek Non-Invasive Bilirubin Analyzer, a handheld device designed for measuring bilirubin levels without requiring blood draws, and the SimpleChoice 3.0 mL Reservoir Pro, a single-use reservoir for medical fluid management.
The company’s products are regulated under FDA’s 510(k) pathway, with devices classified as Class I and Class II. The Bilichek Analyzer and SimpleChoice Reservoir Pro are listed in the FDA’s 510(k) database, and the company is based in the United States.
Catalogue
Bilichek Non-Invasive Bilirubin Analyzer Ref K994438
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Spectrx, Inc. have in the registry?
The registry currently lists 2 devices for Spectrx, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Spectrx, Inc.'s devices?
Among its 2 most recently registered devices, Spectrx, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Spectrx, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Spectrx, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Spectrx, Inc. in the registry?
The most recently registered devices listed for Spectrx, Inc. include BILICHEK NON-INVASIVE BILIRUBIN ANALYZER and SIMPLECHOICE 3.0 ML RESERVOIR PRO REFERENCE NUMBER RP-30.