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SPECTRAL CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I 3-IN-1 TEST

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K030057
510(k) Type
Traditional
Applicant
SPECTRAL DIAGNOSTICS, INC.
Country
Canada
FDA Decision
Substantially Equivalent
Decision Date
3/19/2003
Days to Decision
71 days
Submission Type
Statement

SPECTRAL CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I 3-IN-1 TEST

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K030057
510(k) Type
Traditional
Applicant
SPECTRAL DIAGNOSTICS, INC.
Country
Canada
FDA Decision
Substantially Equivalent
Decision Date
3/19/2003
Days to Decision
71 days
Submission Type
Statement