AMYLASE ULTRAZYME PLUS— 510(k) K771388

Substantially Equivalent

Harleco

FDA 510(k) clearance K771388 for AMYLASE ULTRAZYME PLUS, Substantially Equivalent on 1977-09-02. Applicant: Harleco.

Clearance details

Applicant: Harleco
Product code: Code JFJ
Advisory panel: Clinical Chemistry
Date received: 1977-07-27
Decision date: 1977-09-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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