DeviceClearance

CARDIOZYME PLUS CK-MB ITEM #65045 (G)— 510(k) K811575

Substantially Equivalent

Harleco

FDA 510(k) clearance K811575 for CARDIOZYME PLUS CK-MB ITEM #65045 (G), Substantially Equivalent on 1981-06-25. Applicant: Harleco.

Clearance details

Applicant
Harleco
Product code
Code JHW
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.