Last synced on 14 November 2025 at 11:06 pm

ARCHITECT STAT TROPONIN-I IMMUNOASSAY

Page Type
Cleared 510(K)
510(k) Number
K041192
510(k) Type
Traditional
Applicant
FISHER DIAGNOSTICS
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/12/2004
Days to Decision
98 days
Submission Type
Summary

ARCHITECT STAT TROPONIN-I IMMUNOASSAY

Page Type
Cleared 510(K)
510(k) Number
K041192
510(k) Type
Traditional
Applicant
FISHER DIAGNOSTICS
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/12/2004
Days to Decision
98 days
Submission Type
Summary