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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, neisseria
510(K) Number K935833
Device Name LCX NEISSERIA GONORRHOEAE ASSAY
Applicant
ABBOTT LABORATORIES
dept: 09v8 bldg: ap5-2
100 abbott park road
abbott park,  IL  60064 3500
Contact mary spiewak
Regulation Number866.3390
Classification Product Code
LSL  
Date Received12/07/1993
Decision Date 05/06/1996
Decision substantially equivalent (SE)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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