CHOLESTEROL— 510(k) K850938

Substantially Equivalent

Dilab, Inc.

FDA 510(k) clearance K850938 for CHOLESTEROL, Substantially Equivalent on 1985-06-25. Applicant: Dilab, Inc.. Device class: 1.

Clearance details

Applicant: Dilab, Inc.
Product code: Code CGO
Device class: Class 1
Regulation: 21 CFR 862.1175
Advisory panel: Clinical Chemistry
Date received: 1985-03-07
Decision date: 1985-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, 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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