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ACCESS ACCUTNI REAGENT, ACCESS ACCUTNI CALIBRATOR, UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

Page Type
Cleared 510(K)
510(k) Number
K121790
510(k) Type
Traditional
Applicant
BECKMAN COULTER, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/25/2013
Days to Decision
464 days
Submission Type
Summary

ACCESS ACCUTNI REAGENT, ACCESS ACCUTNI CALIBRATOR, UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

Page Type
Cleared 510(K)
510(k) Number
K121790
510(k) Type
Traditional
Applicant
BECKMAN COULTER, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/25/2013
Days to Decision
464 days
Submission Type
Summary