GENZYME A-AMYLASE TEST REAGENT— 510(k) K933397

Substantially Equivalent

Genzyme Corp.

FDA 510(k) clearance K933397 for GENZYME A-AMYLASE TEST REAGENT, Substantially Equivalent on 1993-10-28. Applicant: Genzyme Corp..

Clearance details

Applicant: Genzyme Corp.
Product code: Code JFJ
Advisory panel: Clinical Chemistry
Date received: 1993-07-12
Decision date: 1993-10-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cambridge, MA, US

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