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DIMENSION TNI FLEX REAGENT CARTRIDGE, AND CTNI SAMPLE DILUENT WITH MODELS, RF621, KD692

Page Type
Cleared 510(K)
510(k) Number
K081643
510(k) Type
Special
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/3/2008
Days to Decision
21 days
Submission Type
Summary

DIMENSION TNI FLEX REAGENT CARTRIDGE, AND CTNI SAMPLE DILUENT WITH MODELS, RF621, KD692

Page Type
Cleared 510(K)
510(k) Number
K081643
510(k) Type
Special
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/3/2008
Days to Decision
21 days
Submission Type
Summary