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 Enzymatic Esterase--Oxidase, Cholesterol
510(k) Number K111753
Device Name HITACHI CLINICAL ANALYZER S TEST REAGENT CATRIDGE FOR: CHOLESTROL, HDL, LDL, AND TRIGLYCERIDE
Applicant
HITACHI CHEMICAL DIAGNOSTICS, INC.
575 Shirlynn Court
Los Altos,  CA  94022
Applicant Contact ERIKA B AMMIRATI, RAC, MT (ASCP)
Correspondent
HITACHI CHEMICAL DIAGNOSTICS, INC.
575 Shirlynn Court
Los Altos,  CA  94022
Correspondent Contact ERIKA B AMMIRATI, RAC, MT (ASCP)
Regulation Number862.1175
Classification Product Code
CHH  
Subsequent Product Codes
CDT   JJE   LBS   MRR  
Date Received06/22/2011
Decision Date 12/14/2011
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
Predetermined Change
Control Plan Authorized		 No
-
-