GEMSAEC APPLI. FOR ULTRAZYME PLUS Y-AMYL— 510(k) K772035

Substantially Equivalent

Harleco

FDA 510(k) clearance K772035 for GEMSAEC APPLI. FOR ULTRAZYME PLUS Y-AMYL, Substantially Equivalent on 1977-11-17. Applicant: Harleco.

Clearance details

Applicant: Harleco
Product code: Code JFJ
Advisory panel: Clinical Chemistry
Date received: 1977-10-27
Decision date: 1977-11-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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