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PATHFAST CTNI-II TEST, PATHFAST CTNI CALIBRATORS, PATHFAST SAMPLE DILUENT 2

Page Type
Cleared 510(K)
510(k) Number
K100130
510(k) Type
Traditional
Applicant
MITSUBISHI CHEMICAL MEDIENCE CO
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/16/2011
Days to Decision
482 days
Submission Type
Summary

PATHFAST CTNI-II TEST, PATHFAST CTNI CALIBRATORS, PATHFAST SAMPLE DILUENT 2

Page Type
Cleared 510(K)
510(k) Number
K100130
510(k) Type
Traditional
Applicant
MITSUBISHI CHEMICAL MEDIENCE CO
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/16/2011
Days to Decision
482 days
Submission Type
Summary