EZ LDL CHOLESTEROL TEST SYSTEM— 510(k) K993741

Substantially Equivalent

Sigma Diagnostics, Inc.

FDA 510(k) clearance K993741 for EZ LDL CHOLESTEROL TEST SYSTEM, Substantially Equivalent on 2000-07-03. Applicant: Sigma Diagnostics, Inc..

Clearance details

Applicant: Sigma Diagnostics, Inc.
Product code: Code MRR
Advisory panel: Clinical Chemistry
Date received: 1999-11-04
Decision date: 2000-07-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

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