ULTRAZYME PLUS LDH— 510(k) K821878

Substantially Equivalent

Harleco Diagnostics

FDA 510(k) clearance K821878 for ULTRAZYME PLUS LDH, Substantially Equivalent on 1982-07-14. Applicant: Harleco Diagnostics.

Clearance details

Applicant: Harleco Diagnostics
Product code: Code CFJ
Advisory panel: Clinical Chemistry
Date received: 1982-06-25
Decision date: 1982-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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