ACCUCLOT THROMBIN TIME REAGENT MODEL A8713/A4589— 510(k) K982209

Substantially Equivalent

Sigma Diagnostics, Inc.

FDA 510(k) clearance K982209 for ACCUCLOT THROMBIN TIME REAGENT MODEL A8713/A4589, Substantially Equivalent on 1998-10-15. Applicant: Sigma Diagnostics, Inc..

Clearance details

Applicant: Sigma Diagnostics, Inc.
Product code: Code GJA
Advisory panel: Hematology
Date received: 1998-06-23
Decision date: 1998-10-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

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