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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name dna probe, nucleic acid amplification, chlamydia
510(k) Number K080739
Device Name ABBOTT REALTIME CT/NG ASSAY AND MULTI-COLLECT SPECIMEN COLLECTION KIT
Original Applicant
ABBOTT MOLECULAR, INC.
1300 east touhy avenue
des plaines,  IL  60018
Original Contact paula e martin
Regulation Number866.3120
Classification Product Code
MKZ  
Subsequent Product Code
LSL  
Date Received03/17/2008
Decision Date 07/10/2008
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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