Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 Capillary Blood Collection Device For Alternative Site Collection
510(k) Number K161521
Device Name TAP Blood Collection Device
Applicant
Seventh Sense Biosystems, Inc.
200 Boston Ave.
Suite 3700
Medford,  MA  02155
Applicant Contact TIM RICHARDS
Correspondent
Sharon Timberlake Consulting, LLC
27 Dunelm Rd.
Bedford,  MA  01730
Correspondent Contact Sharon Timberlake
Regulation Number862.1675
Classification Product Code
PRJ  
Date Received06/02/2016
Decision Date 02/16/2017
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
Predetermined Change
Control Plan Authorized		 No
-
-