ULTRA N-GENEOUS HDL CHOLESTEROL REAGENT 1/REAGENT2; ULTRA N-GENEOUS HDL CHOLESTREOL CALIBRATOR— 510(k) K021316

Clearance details

Applicant

Genzyme Corp.

Product code

Code LBS

Device class

Class 1

Regulation

21 CFR 862.1475

Advisory panel

Clinical Chemistry

Date received

2002-04-25

Decision date

2002-07-25

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Cambridge, MA, US

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