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APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K061377
510(k) Type
Traditional
Applicant
POINTE SCIENTIFIC, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/28/2007
Days to Decision
315 days
Submission Type
Statement

APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K061377
510(k) Type
Traditional
Applicant
POINTE SCIENTIFIC, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/28/2007
Days to Decision
315 days
Submission Type
Statement