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SPECTRAL'S TROPONIN I

Page Type
Cleared 510(K)
510(k) Number
K014105
510(k) Type
Traditional
Applicant
SPECTRAL DIAGNOSTICS, INC.
Country
Canada
FDA Decision
Substantially Equivalent
Decision Date
2/1/2002
Days to Decision
50 days
Submission Type
Statement

SPECTRAL'S TROPONIN I

Page Type
Cleared 510(K)
510(k) Number
K014105
510(k) Type
Traditional
Applicant
SPECTRAL DIAGNOSTICS, INC.
Country
Canada
FDA Decision
Substantially Equivalent
Decision Date
2/1/2002
Days to Decision
50 days
Submission Type
Statement