URITEST - NITRITE IN URINE TEST
FDA 510(k) clearance K954685 · decided 1996-07-22
Clearance details
- K-number
- K954685
- Device name
- URITEST - NITRITE IN URINE TEST
- Applicant
- Tcpi, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-10-11
- Decision date
- 1996-07-22
- Days to decision
- 285 days
- Clearance type
- Traditional
- Product code
- JMT
- Device class
- 1
- Regulation number
- 862.1510
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Beverly, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Healgen® URS Test Strips (K251800) | Healgen Scientific,, LLC | 2025-12-23 |
| AllTest Urinary Tract Infection Test (K252607) | Hangzhou AllTest Biotech Co., Ltd. | 2025-10-30 |
| Safecare Urinary Tract Infection Test (K242767) | Safecare Biotech (Hangzhou) Co., Ltd. | 2025-01-10 |
| Scanostics UTI Check Application Test System (K170118) | Teco Diagnostics | 2017-09-21 |
| TECO DIAGNOSTICS UTI DETECTION STRIPS (K100024) | Teco Diagnostics | 2011-02-17 |
| URINALYSIS REAGENT STRIPS (10 PARAMETERS) (K993850) | International Newtech Development, Inc. | 2000-01-03 |
| DBEST URINARY TRACT INFECTION TEST KIT FOR HOME-USE (K990873) | Ameritek, Inc. | 1999-09-01 |
| CHEK-STIX U.T.I. SELF-TEST (K960888) | Bayer Corp. | 1996-07-05 |
| FIRST CHOICE URINARY TRACT INFECTION TEST STRIPS (K953672) | Polymer Technology Intl. | 1996-07-01 |
| BIOSCAN URINE DIAGNOSTIC REAGENT STRIPS (K875248) | Bioscan Instruments, Inc. | 1988-02-24 |
| BIOTEL (TM)/UTI (K855238) | American Diagnostic Corp. | 1986-05-09 |
| KYOTEST 8V (K840828) | Kyoto Diagnostics, Inc. | 1984-05-14 |
Recalls involving this device
No recalls on record reference this clearance.