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 NameHenry Schein OneStepPlus Urine Analyzer  
Document NumberK061742
Parent Document NumberK061742
Analyte NameUrine qualitative dipstick urobilinogen
Analyte SpecialtyUrinalysis
ComplexityWAIVED
Effective Date05/28/2008
Device Classification Name Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
510(k) Number K061742
Device Name URYXXON RELAX URINE ANALYZER
Applicant
Macherey-Nagel GmbH & Co. KG
7361 Calhoun Pl., Suite 500
Rockville,  MD  20855
Applicant Contact ARMOND WELCH
Correspondent
Macherey-Nagel GmbH & Co. KG
7361 Calhoun Pl., Suite 500
Rockville,  MD  20855
Correspondent Contact ARMOND WELCH
Regulation Number862.1340
Classification Product Code
JIL  
Subsequent Product Codes
CDM   CEN   JIN   JIP   JIR  
JJB   JMA   JMT   KQO   KSL   LJX  
Date Received06/20/2006
Decision Date 09/06/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-