UNIPAK CHOLESTEROL— 510(k) K771093

Substantially Equivalent

Harleco

FDA 510(k) clearance K771093 for UNIPAK CHOLESTEROL, Substantially Equivalent on 1977-07-21. Applicant: Harleco. Device class: 1.

Clearance details

Applicant: Harleco
Product code: Code CGO
Device class: Class 1
Regulation: 21 CFR 862.1175
Advisory panel: Clinical Chemistry
Date received: 1977-06-16
Decision date: 1977-07-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Recent devices under product code CGO

K850938 — CHOLESTEROL1985-06-25
K811747 — KING DIAGNOSTICS CHOLESTEROL TEST1981-07-10
K810090 — CHOLESTEROL REAGENT1981-01-26
K800682 — REAGENTS FOR DETERM. CHOLESTEROL/SERUM1980-05-28
K781611 — CHOLESTEROL DET. IN SERUM1978-10-24

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.