Bioscan Reagent Strips
by Bioscan Instruments, Inc. 510(k)
Active
510(k) K940043
Overview
Bioscan Reagent Strips are a method, enzymatic, glucose (urinary, non-quantitative) test device used in clinical chemistry. They are designed for the detection of glucose in urine samples without providing a quantitative measurement.
The device is supplied as reagent strips and is intended for in vitro diagnostic use. It received FDA 510(k) clearance (K940043) on April 12, 1994, and is classified as a Class II medical device under regulation 862.1340 with product code JIL.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK940043 | Date12 Apr 1994 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- JIL
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1340
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Other devices from Bioscan Instruments, Inc.
Questions
What is the Bioscan Reagent Strips used for?
The Bioscan Reagent Strips are used for the detection of glucose in urine samples without providing a quantitative measurement, as an enzymatic, non-quantitative test device in clinical chemistry.
How are the Bioscan Reagent Strips supplied and intended for use?
The device is supplied as reagent strips and is intended for in vitro diagnostic use to detect glucose in urine samples.
What regulatory clearance does the Bioscan Reagent Strips have?
The Bioscan Reagent Strips received FDA 510(k) clearance (K940043) on April 12, 1994, and is classified as a Class II medical device under regulation 862.1340 with product code JIL.