SIGMA DIAGNOSTICS ACCUCOLOR ANTITHROMBIN III— 510(k) K972144

Substantially Equivalent

Sigma Diagnostics, Inc.

FDA 510(k) clearance K972144 for SIGMA DIAGNOSTICS ACCUCOLOR ANTITHROMBIN III, Substantially Equivalent on 1997-07-25. Applicant: Sigma Diagnostics, Inc..

Clearance details

Applicant: Sigma Diagnostics, Inc.
Product code: Code JBQ
Advisory panel: Hematology
Date received: 1997-06-06
Decision date: 1997-07-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

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