HDL EZ-TZ3 CHOLESTEROL REAGENT KIT— 510(k) K840677

Name: FDA 510(k) clearance K840677
Creator: U.S. Food and Drug Administration
Published: 1984-04-13

Substantially Equivalent

Preventive Diagnostics Corp.

FDA 510(k) clearance K840677 for HDL EZ-TZ3 CHOLESTEROL REAGENT KIT, Substantially Equivalent on 1984-04-13. Applicant: Preventive Diagnostics Corp.. Device class: 1.

Clearance details

Applicant: Preventive Diagnostics Corp.
Product code: Code LBS
Device class: Class 1
Regulation: 21 CFR 862.1475
Advisory panel: Clinical Chemistry
Date received: 1984-02-15
Decision date: 1984-04-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Preventive Diagnostics Corp.

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K840676 — PDC HDL EZ-SEP CHOLESTEROL REAGENT1984-04-04
K840189 — TOTAL CHOLESTEROL REAGENT SET1984-03-23
K840217 — CHOLESTEROL AQUEOUS STANDARD1984-03-23
K840218 — TRIGLYCERIDE AQUEOUS STANDARDS1984-03-23
K840219 — TRIGLYCERIDE/CHOLESTEROL AQUEOUS1984-03-23

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