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 Multiple Use Blood Lancet For Single Patient Use Only
510(k) Number K214022
Device Name Accu-Chek Softclix Blood Lancing System
Applicant
Roche Diabetes Care, Inc.
9115 Hague Rd.
Indianapolos,  IN  46250
Applicant Contact Cameron Smith
Correspondent
Roche Diabetes Care, Inc.
9115 Hague Rd.
Indianapolos,  IN  46250
Correspondent Contact Cameron Smith
Regulation Number878.4850
Classification Product Code
QRL  
Subsequent Product Code
QRK  
Date Received12/22/2021
Decision Date 02/17/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-