EZ HDL CHOLESTEROL REAGENT(PROCEDURE 354)/EZ HDL CALIBRATOR (354-5)— 510(k) K972041

Substantially Equivalent

Sigma Diagnostics, Inc.

FDA 510(k) clearance K972041 for EZ HDL CHOLESTEROL REAGENT(PROCEDURE 354)/EZ HDL CALIBRATOR (354-5), Substantially Equivalent on 1997-07-22. Applicant: Sigma Diagnostics, Inc..

Clearance details

Applicant: Sigma Diagnostics, Inc.
Product code: 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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