ACCUPROBE STREPTOCOCCUS PNEUMONIAE CULTURE CONFIR.

Dna-probe, Strep Pneumoniae

GEN-PROBE, INC.

The following data is part of a premarket notification filed by Gen-probe, Inc. with the FDA for Accuprobe Streptococcus Pneumoniae Culture Confir..

Pre-market Notification Details

Device IDK902908
510k NumberK902908
Device Name:ACCUPROBE STREPTOCOCCUS PNEUMONIAE CULTURE CONFIR.
ClassificationDna-probe, Strep Pneumoniae
Applicant GEN-PROBE, INC. 9880 CAMPUS POINT DR. San Diego,  CA  92121
ContactConnie Kirby
CorrespondentConnie Kirby
GEN-PROBE, INC. 9880 CAMPUS POINT DR. San Diego,  CA  92121
Product CodeMCT  
CFR Regulation Number866.3740 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-07-02
Decision Date1990-08-06

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
15420045506176 K902908 000

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