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VIDAS TROPONIN I ULTRA (TNIU) ASSAY, MODEL 30 448

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K063243
510(k) Type
Traditional
Applicant
BIOMERIEUX, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/14/2007
Days to Decision
414 days
Submission Type
Summary

VIDAS TROPONIN I ULTRA (TNIU) ASSAY, MODEL 30 448

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K063243
510(k) Type
Traditional
Applicant
BIOMERIEUX, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/14/2007
Days to Decision
414 days
Submission Type
Summary