Last synced on 6 December 2024 at 11:05 pm

Xpert CT/NG, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems, GeneXpert Infinity-48 System, Xpert Vaginal/Endocervical Specimen Collection, Xpert Urine Specimen Collection Kit, Xpert Swab Specimen Collection Kit

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K190441
510(k) Type
Traditional
Applicant
Cepheid
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/23/2019
Days to Decision
87 days
Submission Type
Summary

Xpert CT/NG, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems, GeneXpert Infinity-48 System, Xpert Vaginal/Endocervical Specimen Collection, Xpert Urine Specimen Collection Kit, Xpert Swab Specimen Collection Kit

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K190441
510(k) Type
Traditional
Applicant
Cepheid
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/23/2019
Days to Decision
87 days
Submission Type
Summary