J&S HDL CHOLESTEROL PRECIPITATING REAGENT— 510(k) K900218

Name: FDA 510(k) clearance K900218
Creator: U.S. Food and Drug Administration
Published: 1990-06-18

Substantially Equivalent

J.S. Medical Assoc.

FDA 510(k) clearance K900218 for J&S HDL CHOLESTEROL PRECIPITATING REAGENT, Substantially Equivalent on 1990-06-18. Applicant: J.S. Medical Assoc.. Device class: 2.

Clearance details

Applicant: J.S. Medical Assoc.
Product code: Code LBL
Device class: Class 2
Regulation: 21 CFR 874.3880
Advisory panel: Ear, Nose, Throat
Date received: 1990-01-17
Decision date: 1990-06-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Natick, MA, US

Download summary PDF View on FDA.gov ↗

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