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INSTRINSIC FACTOR AB, CALIBRATORS, AND QC ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 387992, 387993, 387999

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K033603
510(k) Type
Traditional
Applicant
BECKMAN COULTER, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/19/2003
Days to Decision
32 days
Submission Type
Summary

INSTRINSIC FACTOR AB, CALIBRATORS, AND QC ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 387992, 387993, 387999

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K033603
510(k) Type
Traditional
Applicant
BECKMAN COULTER, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/19/2003
Days to Decision
32 days
Submission Type
Summary