Bioscan Instruments, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 2
What Bioscan Instruments, Inc. makes
Bioscan Instruments, Inc. manufactures urine diagnostic reagent strips and related reagent-based test strips for medical use, designed to detect specific substances in urine samples.
The company’s products are regulated under FDA’s 510(k) pathway, with devices classified as Class I and Class II. These products are listed in the FDA’s 510(k) clearance registry and are intended for use in the United States.
Catalogue
Bioscan Reagent Strips Ref K940043
510(k) 510(k)Bioscan Urine Diagnostic Reagent Strips Ref K875248
510(k) 510(k)
Frequently asked questions
How many devices does Bioscan Instruments, Inc. have in the registry?
The registry currently lists 2 devices for Bioscan Instruments, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bioscan Instruments, Inc.'s devices?
Among its 2 most recently registered devices, Bioscan Instruments, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Bioscan Instruments, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Bioscan Instruments, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Bioscan Instruments, Inc. in the registry?
The most recently registered devices listed for Bioscan Instruments, Inc. include BIOSCAN REAGENT STRIPS and BIOSCAN URINE DIAGNOSTIC REAGENT STRIPS.