Last synced on 25 January 2026 at 3:41 am

ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL #33340, 33345

Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K021814
510(k) Type
Traditional
Applicant
Beckman Coulter, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/27/2002
Days to Decision
116 days
Submission Type
Summary

ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL #33340, 33345

Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K021814
510(k) Type
Traditional
Applicant
Beckman Coulter, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/27/2002
Days to Decision
116 days
Submission Type
Summary