ACCUPACE GROUP A STREPTOCOCCUS ID TEST

Dna-probe, Reagents, Streptococcal

GEN-PROBE, INC.

The following data is part of a premarket notification filed by Gen-probe, Inc. with the FDA for Accupace Group A Streptococcus Id Test.

Pre-market Notification Details

Device IDK915852
510k NumberK915852
Device Name:ACCUPACE GROUP A STREPTOCOCCUS ID TEST
ClassificationDna-probe, Reagents, Streptococcal
Applicant GEN-PROBE, INC. 9880 CAMPUS POINT DR. San Diego,  CA  92121
ContactRuben Chirez
CorrespondentRuben Chirez
GEN-PROBE, INC. 9880 CAMPUS POINT DR. San Diego,  CA  92121
Product CodeMDK  
CFR Regulation Number866.3740 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-12-27
Decision Date1992-04-02

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