Last synced on 14 November 2025 at 11:06 pm

COBAS C TINA-QUANT CYSTATIN C GEN.2 ASSAY, C.F.A.S. CYSTATIN C CALIBRATOR, CYSTATIN C GEN.2 CONTROL SET

Page Type
Cleared 510(K)
510(k) Number
K141143
510(k) Type
Traditional
Applicant
Roche Diagnostics
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/17/2014
Days to Decision
76 days
Submission Type
Summary

COBAS C TINA-QUANT CYSTATIN C GEN.2 ASSAY, C.F.A.S. CYSTATIN C CALIBRATOR, CYSTATIN C GEN.2 CONTROL SET

Page Type
Cleared 510(K)
510(k) Number
K141143
510(k) Type
Traditional
Applicant
Roche Diagnostics
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/17/2014
Days to Decision
76 days
Submission Type
Summary