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


New Search Back To Search Results
Device Classification Name respiratory virus panel nucleic acid assay system
510(k) Number K113323
Device Name ARTUS INFL A/B RG RT-PCR KIT
Original Applicant
QIAGEN, GMBH
1201 clopper rd
gaithersburg,  MD  20878
Original Contact kim davis
Regulation Number866.3980
Classification Product Code
OCC  
Subsequent Product Codes
JJH   OOI  
Date Received11/10/2011
Decision Date 02/06/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-