ULTRA ZYME PLUS AMYL #64982 & 65031— 510(k) K812594

Substantially Equivalent

Harleco

FDA 510(k) clearance K812594 for ULTRA ZYME PLUS AMYL #64982 & 65031, Substantially Equivalent on 1981-10-02. Applicant: Harleco.

Clearance details

Applicant
Harleco
Product code
Code CIJ
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.