GENZYME DIRECT AMYLASE VERIFIER— 510(k) K993132

Substantially Equivalent

Genzyme Corp.

FDA 510(k) clearance K993132 for GENZYME DIRECT AMYLASE VERIFIER, Substantially Equivalent on 1999-10-04. Applicant: Genzyme Corp.. Device class: 2.

Clearance details

Applicant: Genzyme Corp.
Product code: Code JIT
Device class: Class 2
Regulation: 21 CFR 862.1150
Advisory panel: Clinical Chemistry
Date received: 1999-09-20
Decision date: 1999-10-04
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Cambridge, MA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.