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COBAS C 501 TINA-QUANT HBA1CDX GEN.3 ASSAY

Page Type
Cleared 510(K)
510(k) Number
K121610
510(k) Type
Traditional
Applicant
ROCHE DIAGNOSTICS OPERATIONS
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/8/2013
Days to Decision
433 days
Submission Type
Summary

COBAS C 501 TINA-QUANT HBA1CDX GEN.3 ASSAY

Page Type
Cleared 510(K)
510(k) Number
K121610
510(k) Type
Traditional
Applicant
ROCHE DIAGNOSTICS OPERATIONS
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/8/2013
Days to Decision
433 days
Submission Type
Summary