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 multi-analyte controls, all kinds (assayed)
510(k) Number K072892
Device Name TRIAGE TOTAL CONTROLS 5, TRIAGE TOTAL CALIBRATION VERIFICATION 5
Applicant
BIOSITE INCORPORATED
9975 SUMMERS RIDGE RD
SAN DIEGO,  CA  92121
Applicant Contact FIL V BUENVIAJE
Correspondent
BIOSITE INCORPORATED
9975 SUMMERS RIDGE RD
SAN DIEGO,  CA  92121
Correspondent Contact FIL V BUENVIAJE
Regulation Number862.1660
Classification Product Code
JJY  
Date Received10/10/2007
Decision Date 12/07/2007
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
Recalls CDRH Recalls
-
-