GEN-PROBE AMPLIFIED CHLAMYDIA TRACHOMATIS ASSAY KIT

Dna Probe, Nucleic Acid Amplification, Chlamydia

GEN-PROBE, INC.

The following data is part of a premarket notification filed by Gen-probe, Inc. with the FDA for Gen-probe Amplified Chlamydia Trachomatis Assay Kit.

Pre-market Notification Details

Device IDK962217
510k NumberK962217
Device Name:GEN-PROBE AMPLIFIED CHLAMYDIA TRACHOMATIS ASSAY KIT
ClassificationDna Probe, Nucleic Acid Amplification, Chlamydia
Applicant GEN-PROBE, INC. 9880 CAMPUS POINT DR. San Diego,  CA  92121
ContactGerald H Schell
CorrespondentGerald H Schell
GEN-PROBE, INC. 9880 CAMPUS POINT DR. San Diego,  CA  92121
Product CodeMKZ  
CFR Regulation Number866.3120 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-06-10
Decision Date1996-11-27
Summary:summary

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