ACCUPROBE COCCIDIOIDES IMMITIS CULTURE CONFIRM.

Dna-probe, Reagents, Coccidioides Immitis

GEN-PROBE, INC.

The following data is part of a premarket notification filed by Gen-probe, Inc. with the FDA for Accuprobe Coccidioides Immitis Culture Confirm..

Pre-market Notification Details

Device IDK904047
510k NumberK904047
Device Name:ACCUPROBE COCCIDIOIDES IMMITIS CULTURE CONFIRM.
ClassificationDna-probe, Reagents, Coccidioides Immitis
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 CodeMDF  
CFR Regulation Number866.3135 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-09-04
Decision Date1990-10-02

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
15420045506206 K904047 000

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