• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back To Search Results
Device Classification Name diazo (colorimetric), nitrite (urinary, non-quant)
510(k) Number K170118
Device Name Scanostics UTI Check Application Test System
Teco Diagnostics
1268 N Lakeview Ave
anaheim,  CA  92807
Applicant Contact ling koh
Teco Diagnostics
1268 N Lakeview Ave
anaheim,  CA  92807
Correspondent Contact ling koh
Regulation Number862.1510
Classification Product Code
Subsequent Product Codes
Date Received01/13/2017
Decision Date 09/21/2017
Decision substantially equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No