Last synced on 14 November 2025 at 11:06 pm

TROPONIN I ULTRA ASSAY AND CALIBRATOR FOR THE ADVIA IMS SYSTEM

Page Type
Cleared 510(K)
510(k) Number
K052503
510(k) Type
Traditional
Applicant
BAYER HEALTHCARE, LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/14/2005
Days to Decision
92 days
Submission Type
Summary

TROPONIN I ULTRA ASSAY AND CALIBRATOR FOR THE ADVIA IMS SYSTEM

Page Type
Cleared 510(K)
510(k) Number
K052503
510(k) Type
Traditional
Applicant
BAYER HEALTHCARE, LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/14/2005
Days to Decision
92 days
Submission Type
Summary