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 Real Time Nucleic Acid Amplification System
510(k) Number K113319
Device Name ROTOR-GENE Q MDX
Applicant
QIAGEN, GMBH
1201 CLOPPER RD
GAITHERSBURG,  MD  20878
Applicant Contact MELISSA MAHALL
Correspondent
QIAGEN, GMBH
1201 CLOPPER RD
GAITHERSBURG,  MD  20878
Correspondent Contact MELISSA MAHALL
Regulation Number862.2570
Classification Product Code
OOI  
Date Received11/10/2011
Decision Date 02/06/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-