CARDIOZYME PLUS CK-TOTAL ITEM #65046— 510(k) K811574

Substantially Equivalent

Harleco

FDA 510(k) clearance K811574 for CARDIOZYME PLUS CK-TOTAL ITEM #65046, Substantially Equivalent on 1981-06-25. Applicant: Harleco. Device class: 2.

Clearance details

Applicant: Harleco
Product code: Code CGS
Device class: Class 2
Regulation: 21 CFR 862.1215
Advisory panel: Clinical Chemistry
Date received: 1981-06-04
Decision date: 1981-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Harleco

K820233 — ULTRAZYME PLUS GAMMA GT(65055-65056)1982-02-12
K813427 — ULTRACHEM GLUC-DH1981-12-31
K813038 — ULTRACHEM TP, ITEM #649741981-11-10
K813039 — ULTRACHEM E-CHOL, ITEM #650251981-11-10
K813040 — ULTRACHEM CA, ITEM #649751981-11-10

Data sourced from openFDA. This site is unofficial and independent of the FDA.