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 calibrator, multi-analyte mixture
510(k) Number K051457
Device Name SENTINEL PLASMAPROTEINS CAL 3X
Applicant
SENTINEL CH. SRL
5 VIA PRINCIPE EUGENIO
MILANO,  IT 20155
Applicant Contact DAVIDE SPADA
Correspondent
SENTINEL CH. SRL
5 VIA PRINCIPE EUGENIO
MILANO,  IT 20155
Correspondent Contact DAVIDE SPADA
Regulation Number862.1150
Classification Product Code
JIX  
Date Received06/02/2005
Decision Date 07/25/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
-
-