DeviceClearance

ULTRAZYME PLUS AMYL— 510(k) K821869

Substantially Equivalent

Harleco Diagnostics

FDA 510(k) clearance K821869 for ULTRAZYME PLUS AMYL, Substantially Equivalent on 1982-07-13. Applicant: Harleco Diagnostics.

Clearance details

Applicant
Harleco Diagnostics
Product code
Code JFJ
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.