SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-A— 510(k) K003267

Substantially Equivalent

Sigma Diagnostics, Inc.

FDA 510(k) clearance K003267 for SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-A, Substantially Equivalent on 2001-03-15. Applicant: Sigma Diagnostics, Inc..

Clearance details

Applicant: Sigma Diagnostics, Inc.
Product code: Code DAP
Advisory panel: Hematology
Date received: 2000-10-18
Decision date: 2001-03-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

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