CHOLESTEROL REAGENT— 510(k) K810090

Name: FDA 510(k) clearance K810090
Creator: U.S. Food and Drug Administration
Published: 1981-01-26

Substantially Equivalent

Anco Medical Reagents & Assoc.

FDA 510(k) clearance K810090 for CHOLESTEROL REAGENT, Substantially Equivalent on 1981-01-26. Applicant: Anco Medical Reagents & Assoc.. Device class: 1.

Clearance details

Applicant: Anco Medical Reagents & Assoc.
Product code: Code CGO
Device class: Class 1
Regulation: 21 CFR 862.1175
Advisory panel: Clinical Chemistry
Date received: 1981-01-13
Decision date: 1981-01-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K800682 — REAGENTS FOR DETERM. CHOLESTEROL/SERUM1980-05-28
K781611 — CHOLESTEROL DET. IN SERUM1978-10-24
K780545 — SR-PLUS DIRECT CHOLESTEROL TEST1978-05-26

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K821526 — ACID PHOSPHATASE REAGENT SET1982-06-10
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Data sourced from openFDA. This site is unofficial and independent of the FDA.