Dbest Urinary Tract Infection Test Kit for Home-Use
FDA 510(k) K990873 · Ameritek, Inc.
510(k) numberK990873
Submission
- Device name
- Dbest Urinary Tract Infection Test Kit for Home-Use
- Applicant
- Ameritek, Inc.
Seattle, WA, US - Received
- March 16, 1999
- Decision date
- September 1, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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|---|---|---|---|
| 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 |
| 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 |
| K875248 | Bioscan Urine Diagnostic Reagent StripsJMT · Traditional | Bioscan Instruments, Inc. | 02/24/1988SE |
More from Bioscan Instruments, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K001215 | Dbest HCG 2 Iu/Ml Test KitJHI · Abbreviated | 06/22/2000SE |
| K990681 | Dbset Multidrug Screen Test KitDKZ · Traditional | 07/15/1999SE |
| K984269 | Dbest Occult Blood Test KitKHE · Traditional | 05/11/1999SE |
| K983191 | Dbest Cocaine Test KitDIO · Traditional | 11/18/1998SE |
| K983190 | Dbest Opiates Test KitDJG · Traditional | 11/18/1998SE |
| K983189 | Dbest Methamphetamines Test KitLAF · Traditional | 11/18/1998SE |
| K983188 | Dbest Tetrahydrocannabinol Test KitLDJ · Traditional | 11/18/1998SE |
| K981504 | Dbest Amphetamines Test KitDKZ · Traditional | 08/06/1998SE |
| K974508 | Dbest One-Step Ovulation TestCEP · Traditional | 02/02/1998SE |
| K973957 | Dbest One-Step HCG Serum/Urine TestJHI · Traditional | 12/17/1997SE |
Questions and answers
When was Dbest Urinary Tract Infection Test Kit for Home-Use cleared by the FDA?
Dbest Urinary Tract Infection Test Kit for Home-Use (K990873) received a 510(k) decision of Substantially Equivalent on September 1, 1999, 169 days after the submission was received.
What is the product code of K990873?
The FDA product code is JMT – Diazo (Colorimetric), Nitrite (Urinary, Non-Quant), a Class I (low risk) device regulated under 21 CFR 862.1510.