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FDA 510(k), K203429, Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System
FDA 510(k), K203429, Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System
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510(K) Number: K203429
Device Name: Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System
Manufacturer: Yi-Ping Lin
Device Classification Name: Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
Regulation Number: NJR
Classification Product Code: 11/20/2020
Date Received: 05/09/2022
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Microbiology
Device Name: Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System
Manufacturer: Yi-Ping Lin
Device Classification Name: Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
Regulation Number: NJR
Classification Product Code: 11/20/2020
Date Received: 05/09/2022
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Microbiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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