PACE 2 SYSTEM FOR CHLAMYDIA TRACHOMATIS

Dna-reagents, Chlamydia

GEN-PROBE, INC.

The following data is part of a premarket notification filed by Gen-probe, Inc. with the FDA for Pace 2 System For Chlamydia Trachomatis.

Pre-market Notification Details

Device IDK920378
510k NumberK920378
Device Name:PACE 2 SYSTEM FOR CHLAMYDIA TRACHOMATIS
ClassificationDna-reagents, Chlamydia
Applicant GEN-PROBE, INC. 9880 CAMPUS POINT DR. San Diego,  CA  92121
ContactRuben Chairez
CorrespondentRuben Chairez
GEN-PROBE, INC. 9880 CAMPUS POINT DR. San Diego,  CA  92121
Product CodeLSK  
CFR Regulation Number866.3120 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-01-29
Decision Date1992-04-29

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