PACE SYSTEM FOR NEISSERIA GONORRHOEAE ADDI. CLAIMS

Dna-reagents, Neisseria

GEN-PROBE, INC.

The following data is part of a premarket notification filed by Gen-probe, Inc. with the FDA for Pace System For Neisseria Gonorrhoeae Addi. Claims.

Pre-market Notification Details

Device IDK881277
510k NumberK881277
Device Name:PACE SYSTEM FOR NEISSERIA GONORRHOEAE ADDI. CLAIMS
ClassificationDna-reagents, Neisseria
Applicant GEN-PROBE, INC. 9880 CAMPUS POINT DR. San Diego,  CA  92121
ContactBruni, Ph.d.
CorrespondentBruni, Ph.d.
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 Received1988-03-18
Decision Date1988-04-25

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