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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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