DART ALPHA-AMYLASE REAGENT SYSTEM— 510(k) K834053

Substantially Equivalent

Coulter Electronics, Inc.

FDA 510(k) clearance K834053 for DART ALPHA-AMYLASE REAGENT SYSTEM, Substantially Equivalent on 1984-02-04. Applicant: Coulter Electronics, Inc..

Clearance details

Applicant: Coulter Electronics, Inc.
Product code: Code CIJ
Advisory panel: Clinical Chemistry
Date received: 1983-11-23
Decision date: 1984-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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