K972041

Substantially Equivalent

EZ HDL CHOLESTEROL REAGENT(PROCEDURE 354)/EZ HDL CALIBRATOR (354-5)

Applicant: Sigma Diagnostics, Inc.
Product code: LBS
Advisory panel: Clinical Chemistry
Date received: 1997-06-02
Decision date: 1997-07-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

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