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ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEM # 33340, 33345

Page Type
Cleared 510(K)
510(k) Number
K010429
510(k) Type
Traditional
Applicant
BECKMAN COULTER, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/5/2001
Days to Decision
112 days
Submission Type
Summary

ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEM # 33340, 33345

Page Type
Cleared 510(K)
510(k) Number
K010429
510(k) Type
Traditional
Applicant
BECKMAN COULTER, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/5/2001
Days to Decision
112 days
Submission Type
Summary