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 hexokinase, glucose
510(k) Number K120369
Device Name HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE GLUCOSE (GLU)
Applicant
HITACHI CHEMICAL DIAGNOSTICS, INC.
630 CLYDE CT.
MOUNTAIN VIEW,  CA  94043
Applicant Contact BUNICHIRO NAKAJIMA
Correspondent
HITACHI CHEMICAL DIAGNOSTICS, INC.
630 CLYDE CT.
MOUNTAIN VIEW,  CA  94043
Correspondent Contact BUNICHIRO NAKAJIMA
Regulation Number862.1345
Classification Product Code
CFR  
Date Received02/06/2012
Decision Date 05/10/2012
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
-
-