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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
Device Name ABBOTT REALTIME CT/NG AND ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, MODELS 8L07-91, 9K12-03
Applicant
Abbott Molecular, Inc.
1300 E Touhy Ave.
Des Plaines,  IL  60018
Applicant Contact PAULA MARTIN
Correspondent
Abbott Molecular, Inc.
1300 E Touhy Ave.
Des Plaines,  IL  60018
Correspondent 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 (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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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