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ACCESS ACCUTNI+3 REAGENT AND ACCESS ACCUTN1+3 CALIBRATORS FOR USE ON THE ACCESS 2 IMMUNOASSAY SYSTEM

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K121214
510(k) Type
Traditional
Applicant
BECKMAN COULTER, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/14/2013
Days to Decision
417 days
Submission Type
Summary

ACCESS ACCUTNI+3 REAGENT AND ACCESS ACCUTN1+3 CALIBRATORS FOR USE ON THE ACCESS 2 IMMUNOASSAY SYSTEM

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K121214
510(k) Type
Traditional
Applicant
BECKMAN COULTER, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/14/2013
Days to Decision
417 days
Submission Type
Summary