• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 

New Search Back To Search Results
Test System NameDade Behring BN II System  
Document NumberK003503
Analyte NameCystacin C
Analyte SpecialtyGeneral Chemistry
ComplexityMODERATE
Effective Date04/16/2001
Device Classification Name test, cystatin c
510(k) Number K003503
Device Name N LATEX CYSTATIN C
Original Applicant
DADE BEHRING, INC.
glasgow business community;
bldg. 500 mail box 514
p.o. box 6101, newark,  DE  19714 -6101
Original Contact rebecca s ayash
Regulation Number862.1225
Classification Product Code
NDY  
Date Received11/13/2000
Decision Date 03/13/2001
Decision substantially equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-