Last synced on 14 November 2025 at 11:06 pm

AU BICARBONATE REAGENT

Page Type
Cleared 510(K)
510(k) Number
K131546
510(k) Type
Traditional
Applicant
Beckman Coulter Ireland, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/9/2013
Days to Decision
133 days
Submission Type
Summary

AU BICARBONATE REAGENT

Page Type
Cleared 510(K)
510(k) Number
K131546
510(k) Type
Traditional
Applicant
Beckman Coulter Ireland, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/9/2013
Days to Decision
133 days
Submission Type
Summary