CARDIOZYME PLUS CK-TOTAL ITEM #65046 (A)— 510(k) K811576

Substantially Equivalent

Harleco

FDA 510(k) clearance K811576 for CARDIOZYME PLUS CK-TOTAL ITEM #65046 (A), Substantially Equivalent on 1981-06-25. Applicant: Harleco.

Clearance details

Applicant: Harleco
Product code: Code CGS
Advisory panel: Clinical Chemistry
Date received: 1981-06-04
Decision date: 1981-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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