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COBAS INTEGRA CARBON DIOXIDE ASSAY

Page Type
Cleared 510(K)
510(k) Number
K031879
510(k) Type
Special
Applicant
Roche Diagnostics Corp.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/17/2003
Days to Decision
29 days
Submission Type
Summary

COBAS INTEGRA CARBON DIOXIDE ASSAY

Page Type
Cleared 510(K)
510(k) Number
K031879
510(k) Type
Special
Applicant
Roche Diagnostics Corp.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/17/2003
Days to Decision
29 days
Submission Type
Summary