510(k) K011843— GENZYME DIRECT-AMYLASE TEST REAGENT

Substantially Equivalent

Genzyme Corp.

Clearance details

Applicant: Genzyme Corp.
Product code: Code JFJ
Advisory panel: Clinical Chemistry
Date received: 2001-06-12
Decision date: 2001-08-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cambridge, MA, US

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