Chek-Stix U.T.I. Self-Test
FDA 510(k) K960888 · Bayer Corp.
510(k) numberK960888
Submission
- Device name
- Chek-Stix U.T.I. Self-Test
- Applicant
- Bayer Corp.
Elkhart, IN, US - Received
- March 4, 1996
- Decision date
- July 5, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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
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| 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 |
| K953672 | First Choice Urinary Tract Infection Test StripsJMT · Traditional | Polymer Technology Intl. | 07/01/1996SE |
| K875248 | Bioscan Urine Diagnostic Reagent StripsJMT · Traditional | Bioscan Instruments, Inc. | 02/24/1988SE |
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| K020828 | Ca 125 Assay for the Advia Centaur SystemLTK · Traditional | 07/24/2002SE |
| K021428 | Clinitek Atlas Pro 12 Reagent Pak SystemJFY · Traditional | 07/05/2002SE |
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Questions and answers
When was Chek-Stix U.T.I. Self-Test cleared by the FDA?
Chek-Stix U.T.I. Self-Test (K960888) received a 510(k) decision of Substantially Equivalent on July 5, 1996, 123 days after the submission was received.
What is the product code of K960888?
The FDA product code is JMT – Diazo (Colorimetric), Nitrite (Urinary, Non-Quant), a Class I (low risk) device regulated under 21 CFR 862.1510.