510(k) K013549— SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971

Substantially Equivalent

Sigma Diagnostics, Inc.

Clearance details

Applicant
Sigma Diagnostics, Inc.
Product code
Code DAP
Advisory panel
Hematology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
St. Louis, MO, US
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