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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dna-Probe, Strep Pneumoniae
510(k) Number K902908
Device Name ACCUPROBE STREPTOCOCCUS PNEUMONIAE CULTURE CONFIR.
Applicant
GEN-PROBE, INC.
9880 CAMPUS POINT DR.
SAN DIEGO,  CA  92121
Applicant Contact CONNIE KIRBY
Correspondent
GEN-PROBE, INC.
9880 CAMPUS POINT DR.
SAN DIEGO,  CA  92121
Correspondent Contact CONNIE KIRBY
Regulation Number866.3740
Classification Product Code
MCT  
Date Received07/02/1990
Decision Date 08/06/1990
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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