SIGMA DIAGNOSTICS FIBRINOGEN KIT (886A/887A)— 510(k) K971858

Substantially Equivalent

Sigma Diagnostics, Inc.

FDA 510(k) clearance K971858 for SIGMA DIAGNOSTICS FIBRINOGEN KIT (886A/887A), Substantially Equivalent on 1997-10-09. Applicant: Sigma Diagnostics, Inc..

Clearance details

Applicant: Sigma Diagnostics, Inc.
Product code: Code KQJ
Advisory panel: Hematology
Date received: 1997-05-20
Decision date: 1997-10-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

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