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, secondary
510(k) Number K092937
Device Name STA-HYBRID HEP CALIBRATOR
Applicant
DIAGNOSTICA STAGO, INC.
5 CENTURY DR.
PARSIPPANY,  NJ  07054
Applicant Contact UMBERTO V PARROTTA
Correspondent
DIAGNOSTICA STAGO, INC.
5 CENTURY DR.
PARSIPPANY,  NJ  07054
Correspondent Contact UMBERTO V PARROTTA
Regulation Number862.1150
Classification Product Code
JIT  
Date Received09/24/2009
Decision Date 08/02/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-