SIGMA DIAGNOSTICS ACCUCLOT CONTROL II— 510(k) K981254

Substantially Equivalent

Sigma Diagnostics, Inc.

FDA 510(k) clearance K981254 for SIGMA DIAGNOSTICS ACCUCLOT CONTROL II, Substantially Equivalent on 1998-04-29. Applicant: Sigma Diagnostics, Inc..

Clearance details

Applicant: Sigma Diagnostics, Inc.
Product code: Code GGN
Advisory panel: Hematology
Date received: 1998-04-06
Decision date: 1998-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

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