Chromatics Color Sciences Intl., Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Chromatics Color Sciences Intl., Inc. makes
Chromatics Color Sciences Intl., Inc. manufactures diagnostic systems for bilirubin testing, including the COLORMATE TLC BILITEST SYSTEM and the COLORMATE III. These devices are designed for visual assessment of neonatal jaundice by comparing test strips to color charts, aiding in the evaluation of hyperbilirubinemia in infants.
The company’s products are classified as Class I medical devices under FDA regulations and are supported by 510(k) clearances. The portfolio is listed in the FDA’s 510(k) database, reflecting their regulatory status in the United States.
Catalogue
Colormate Tlc Bilitest System Ref K001687
Regimes: 510(k) Registry: 510(k)Colormate Iii Ref K964590
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Chromatics Color Sciences Intl., Inc. have in the registry?
The registry currently lists 2 devices for Chromatics Color Sciences Intl., Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Chromatics Color Sciences Intl., Inc.'s devices?
Among its 2 most recently registered devices, Chromatics Color Sciences Intl., Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Chromatics Color Sciences Intl., Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Chromatics Color Sciences Intl., Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Chromatics Color Sciences Intl., Inc. in the registry?
The most recently registered devices listed for Chromatics Color Sciences Intl., Inc. include COLORMATE TLC BILITEST SYSTEM and COLORMATE III.