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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name dna-reagents, chlamydia
510(k) Number K092704
Model 8L07-91, 9K12-03
Device Name ABBOTT REALTIME CT/NG AND ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, MODELS 8L07-91, 9K12-03
Original Applicant
ABBOTT MOLECULAR, INC.
1300 east touhy avenue
des plaines,  IL  60018
Original Contact paula martin
Regulation Number866.3120
Classification Product Code
LSK  
Subsequent Product Code
MKZ  
Date Received09/03/2009
Decision Date 05/28/2010
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
Recalls CDRH Recalls
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