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Rickettsia Real-time PCR Assay

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K170940
510(k) Type
Traditional
Applicant
Centers for Disease Control and Prevention (CDC)
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/29/2017
Days to Decision
91 days
Submission Type
Summary

Rickettsia Real-time PCR Assay

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K170940
510(k) Type
Traditional
Applicant
Centers for Disease Control and Prevention (CDC)
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/29/2017
Days to Decision
91 days
Submission Type
Summary