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 Bromcresol Green Dye-Binding, Albumin
510(k) Number K011720
Device Name OLYMPUS AU5400 CLINICAL CHEMISTRY ANALYZER
Applicant
OLYMPUS AMERICA, INC.
3131 WEST ROYAL LN.
IRVING,  TX  75063 -3104
Applicant Contact MICHAEL CAMPBELL
Correspondent
OLYMPUS AMERICA, INC.
3131 WEST ROYAL LN.
IRVING,  TX  75063 -3104
Correspondent Contact MICHAEL CAMPBELL
Regulation Number862.1035
Classification Product Code
CIX  
Subsequent Product Codes
CDO   CDQ   CDT   CEK   CEM  
CEO   CFJ   CFQ   CFR   CGS   CGX  
CGZ   CHH   CHS   CIC   CIG   CIT  
CJE   CKA   CZW   DAD   DBF   DBI  
DCN   DDD   DDR   DDS   DEM   DHR  
GTQ   JFJ   JGJ   JGS   JHH   JHN  
JIR   JIY   JJE   JLB   JMO   JQB  
JZG   LBS   LKL  
Date Received06/04/2001
Decision Date 06/25/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-