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

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
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)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
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