Bioscan Urine Diagnostic Reagent Strips
FDA 510(k) K875248 · Bioscan Instruments, Inc.
510(k) numberK875248
Submission
- Device name
- Bioscan Urine Diagnostic Reagent Strips
- Applicant
- Bioscan Instruments, Inc.
New York, NY, US - Received
- December 22, 1987
- Decision date
- February 24, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JMT – Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1510
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JMT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251800 | Healgen® URS Test StripsJMT · Traditional | Healgen Scientific,, LLC | 12/23/2025SE |
| K252607 | AllTest Urinary Tract Infection TestJMT · Traditional | Hangzhou AllTest Biotech Co., Ltd. | 10/30/2025SE |
| K242767 | Safecare Urinary Tract Infection TestJMT · Traditional | Safecare Biotech (Hangzhou) Co., Ltd. | 01/10/2025SE |
| K170118 | Scanostics UTI Check Application Test SystemJMT · Traditional | Teco Diagnostics | 09/21/2017SE |
| K100024 | Teco Diagnostics Uti Detection StripsJMT · Traditional | Teco Diagnostics | 02/17/2011SE |
| K993850 | Urinalysis Reagent Strips (10 Parameters)JMT · Traditional | International Newtech Development, Inc. | 01/03/2000SE |
| K990873 | Dbest Urinary Tract Infection Test Kit for Home-UseJMT · Traditional | Ameritek, Inc. | 09/01/1999SE |
| K954685 | Uritest - Nitrite in Urine TestJMT · Traditional | Tcpi, Inc. | 07/22/1996SE |
| K960888 | Chek-Stix U.T.I. Self-TestJMT · Traditional | Bayer Corp. | 07/05/1996SE |
| K953672 | First Choice Urinary Tract Infection Test StripsJMT · Traditional | Polymer Technology Intl. | 07/01/1996SE |
More from Polymer Technology Intl.
| 510(k) | Device | Decision |
|---|---|---|
| K940043 | Bioscan Reagent StripsJIL · Traditional | 04/12/1994SE |
Questions and answers
When was Bioscan Urine Diagnostic Reagent Strips cleared by the FDA?
Bioscan Urine Diagnostic Reagent Strips (K875248) received a 510(k) decision of Substantially Equivalent on February 24, 1988, 64 days after the submission was received.
What is the product code of K875248?
The FDA product code is JMT – Diazo (Colorimetric), Nitrite (Urinary, Non-Quant), a Class I (low risk) device regulated under 21 CFR 862.1510.