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 Turbidimetric, Total Protein
510(k) Number K131051
Device Name HITACHI S TEST REAGENT CARTRIDGE TOTAL PROTEIN (TP) AND ALBUMIN (ALB)
Applicant
Hitachi Chemical Diagnostics, Inc.
575 Shirlynn Ct.
Los Angeles,  CA  94022
Applicant Contact ERIKA AMMIRATI
Correspondent
Hitachi Chemical Diagnostics, Inc.
575 Shirlynn Ct.
Los Angeles,  CA  94022
Correspondent Contact ERIKA AMMIRATI
Regulation Number862.1635
Classification Product Code
JGQ  
Subsequent Product Code
CIX  
Date Received04/15/2013
Decision Date 06/07/2013
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
-
-