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ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBIN

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K083260
510(k) Type
Traditional
Applicant
Roche Diagnostics
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/16/2009
Days to Decision
345 days
Submission Type
Summary

ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBIN

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K083260
510(k) Type
Traditional
Applicant
Roche Diagnostics
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/16/2009
Days to Decision
345 days
Submission Type
Summary