Scanostics UTI Check Application Test System— 510(k) K170118
Substantially EquivalentTeco Diagnostics
FDA 510(k) clearance K170118 for Scanostics UTI Check Application Test System, Substantially Equivalent on 2017-09-21. Applicant: Teco Diagnostics. Device class: 1.
Clearance details
- Applicant
- Teco Diagnostics
- Product code
- Code JMT
- Device class
- Class 1
- Regulation
- 21 CFR 862.1510
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Anaheim, CA, US
Recent devices under product code JMT
view allMore clearances from Teco Diagnostics
view all- K141289 — TC-THUNDERBOLT AUTOMATED URINE ANALYZER SYSTEM AND TC-THUNDERBOLT URS-10 STRIPS
- K131600 — URS-2GP (GLUCOSE PROTEIN) URINE STRIPS
- K111206 — TECO DIAGNOSTICS SALIVA ALCOHOL TEST
- K101673 — URITEK TC-101 URINE ANALYZER, URINE REAGENT STRIPS 10, MODELS TC-101, URS-10
- K073370 — TC MATRIX CLINICAL CHEMISTRY ANALYZER
Data sourced from openFDA. This site is unofficial and independent of the FDA.