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CARESTART CARDIAC 3-IN-1 TROPONIN 1/CK-MB/MYOGLOBIN

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K051925
510(k) Type
Traditional
Applicant
ACCESS BIO INCORPORATE
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/29/2005
Days to Decision
134 days
Submission Type
Statement

CARESTART CARDIAC 3-IN-1 TROPONIN 1/CK-MB/MYOGLOBIN

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K051925
510(k) Type
Traditional
Applicant
ACCESS BIO INCORPORATE
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/29/2005
Days to Decision
134 days
Submission Type
Statement