SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096— 510(k) K013544

Substantially Equivalent

Sigma Diagnostics, Inc.

FDA 510(k) clearance K013544 for SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096, Substantially Equivalent on 2001-11-15. Applicant: Sigma Diagnostics, Inc..

Clearance details

Applicant: Sigma Diagnostics, Inc.
Product code: Code DAP
Advisory panel: Hematology
Date received: 2001-10-24
Decision date: 2001-11-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

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