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

CLIA - Clinical Laboratory Improvement Amendments
  • 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
Test System NameRadiometer ABL System 625  
Document NumberK962334
Parent Document NumberK962334
Analyte NameLactic acid (lactate)
Analyte SpecialtyGeneral Chemistry
ComplexityMODERATE
Effective Date03/07/1997
Device Classification Name Electrode, Ion Specific, Sodium
510(k) Number K962334
Device Name EML105 ELECTROLYTE METABOLITE ANALYZER
Applicant
Radiometer America, Inc.
810 Sharon Dr.
Westlake,  OH  44145
Applicant Contact DONALD L BAKER
Correspondent
Radiometer America, Inc.
810 Sharon Dr.
Westlake,  OH  44145
Correspondent Contact DONALD L BAKER
Regulation Number862.1665
Classification Product Code
JGS  
Subsequent Product Codes
CEM   CGA   CGZ   JFP   KHP  
Date Received06/17/1996
Decision Date 10/24/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-