ACCUPROBE NEISSERIA GONORRHOEAE CULTURE CONFIRMA.

Dna-reagents, Neisseria

GEN-PROBE, INC.

The following data is part of a premarket notification filed by Gen-probe, Inc. with the FDA for Accuprobe Neisseria Gonorrhoeae Culture Confirma..

Pre-market Notification Details

Device IDK895583
510k NumberK895583
Device Name:ACCUPROBE NEISSERIA GONORRHOEAE CULTURE CONFIRMA.
ClassificationDna-reagents, Neisseria
Applicant GEN-PROBE, INC. 9880 CAMPUS POINT DR. San Diego,  CA  92121
ContactBruni, Phd
CorrespondentBruni, Phd
GEN-PROBE, INC. 9880 CAMPUS POINT DR. San Diego,  CA  92121
Product CodeLSL  
CFR Regulation Number866.3390 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-09-15
Decision Date1989-11-14

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
15420045506107 K895583 000

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