• 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 semen analysis device
510(k) Number K153683
Device Name Trak Male Fertility Testing System
Applicant
SANDSTONE DIAGNOSTICS, INC.
6111 SOUTHFRONT ROAD, SUITE J
livermore,  CA  94551
Applicant Contact greg sommer
Correspondent
AMMIRATI REGULATORY CONSULTING
575 SHIRLYNN COURT
los altos,  CA  94022
Correspondent Contact erika ammirati
Regulation Number864.5220
Classification Product Code
POV  
Date Received12/22/2015
Decision Date 05/16/2016
Decision substantially equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-