FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
URITEK TC-201 URINE CHEMISTRY TEST SYSTEM
K Number: K160372
·
Decision Jul 22, 2016
Classifications
1
FEI Numbers
52
Registration Numbers
52
Same Product Code
80
Applicant Total
4
Review Days
163
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- URITEK TC-201 URINE CHEMISTRY TEST SYSTEM
- K Number
- K160372
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1340
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Teco Diagnostics, Inc.
- Date Received
- February 10, 2016
- Decision Date
- July 22, 2016
- Product Code
- JIL
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JIL | Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JIL), ordered by most recent decision date.
AUTION MAX AX-4060 Urinalysis System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
cobas u 601 urinalysis test system
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DIP/U.S. Urine Analysis Test System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
inui In-Home Urine Analysis Test System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DUS R-50S (Urine Chemistry system)
FDA 510(k)
FDA Class 2
·Clinical Chemistry