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Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K150358
510(k) Type
Traditional
Applicant
GOLD STANDARD DIAGNOSTICS
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/12/2015
Days to Decision
273 days
Submission Type
Summary

Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K150358
510(k) Type
Traditional
Applicant
GOLD STANDARD DIAGNOSTICS
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/12/2015
Days to Decision
273 days
Submission Type
Summary