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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
Applicant Contact mary spiewak
Correspondent
ABBOTT LABORATORIES
DEPT: 09V8 BLDG: AP5-2
100 ABBOTT PARK ROAD
abbott park,  IL  60064 -3500
Correspondent Contact mary spiewak
Regulation Number866.3390
Classification Product Code
LSL  
Date Received12/07/1993
Decision Date 05/06/1996
Decision substantially equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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