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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 K895583
Device Name ACCUPROBE NEISSERIA GONORRHOEAE CULTURE CONFIRMA.
Applicant
GEN-PROBE, INC.
9880 CAMPUS POINT DR.
SAN DIEGO,  CA  92121
Applicant Contact BRUNI, PHD
Correspondent
GEN-PROBE, INC.
9880 CAMPUS POINT DR.
SAN DIEGO,  CA  92121
Correspondent Contact BRUNI, PHD
Regulation Number866.3390
Classification Product Code
LSL  
Date Received09/15/1989
Decision Date 11/14/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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