ALPHA/CHOL— 510(k) K772043

Substantially Equivalent

Standard Scientific, Inc.

FDA 510(k) clearance K772043 for ALPHA/CHOL, Substantially Equivalent on 1977-11-28. Applicant: Standard Scientific, Inc.. Device class: 1.

Clearance details

Applicant: Standard Scientific, Inc.
Product code: Code CGO
Device class: Class 1
Regulation: 21 CFR 862.1175
Advisory panel: Clinical Chemistry
Date received: 1977-10-28
Decision date: 1977-11-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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

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