Solarcare, Inc.
United StatesFDA applicant, unverified
- Devices
- 6
What Solarcare, Inc. makes
Solarcare, Inc. manufactures in vitro diagnostic devices, including enzyme immunoassays (EIAs) for detecting drugs such as propoxyphene, barbiturates, and cocaine metabolites, as well as automated testing systems like the Auto-Lyte series. The company also produces micro-plate assays for biochemical markers, such as total protein and alanine aminotransferase (ALT). These products are designed for clinical and laboratory use to aid in drug screening and liver function testing.
The company’s portfolio includes devices classified under FDA’s Class I and Class II categories, with regulatory submissions recorded in the FDA’s 510(k) clearance database. Products are intended for use in the United States, where Solarcare, Inc. is based.
Catalogue
Stc Diagnostic Auto-Lyte Propoxyphene Eia Ref K944372
Regimes: 510(k) Registry: 510(k)Histofreezer Ref K933327
Regimes: 510(k) Registry: 510(k)Stc Diagnostics Auto-Lyte Barbiturates Eia Ref K934376
Regimes: 510(k) Registry: 510(k)Stc Cocaine Metabolite Eia Ref K934775
Regimes: 510(k) Registry: 510(k)Solarcare Total Protein Micro-Plate Assay Ref K941496
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Solarcare, Inc. have in the registry?
The registry currently lists 6 devices for Solarcare, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Solarcare, Inc.'s devices?
Among its 6 most recently registered devices, Solarcare, Inc. has devices listed in FDA 510(k) (6 devices).
What risk classes do Solarcare, Inc.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Solarcare, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Solarcare, Inc. in the registry?
The most recently registered devices listed for Solarcare, Inc. include STC DIAGNOSTIC AUTO-LYTE PROPOXYPHENE EIA, HISTOFREEZER, STC DIAGNOSTICS AUTO-LYTE BARBITURATES EIA and STC COCAINE METABOLITE EIA.