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TROPONIN I ASSAY FOR THE BAYER IMMUNO 1 SYSTEM

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K973616
510(k) Type
Traditional
Applicant
BAYER CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/5/1997
Days to Decision
73 days
Submission Type
Summary

TROPONIN I ASSAY FOR THE BAYER IMMUNO 1 SYSTEM

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K973616
510(k) Type
Traditional
Applicant
BAYER CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/5/1997
Days to Decision
73 days
Submission Type
Summary