Cleared Traditional

IMMUNOTECH HDL-CHOLESTEROL TEST

K900036 · Immunotech Corp. · Chemistry

Mar 1990

Decision

66d

Days

Class 1

Risk

About This 510(k) Submission

K900036 is an FDA 510(k) clearance for the IMMUNOTECH HDL-CHOLESTEROL TEST, a Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl (Class I — General Controls, product code LBS), submitted by Immunotech Corp. (Boston, US). The FDA issued a Cleared decision on March 9, 1990, 66 days after receiving the submission on January 2, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1475.

Submission Details

510(k) Number	K900036 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 02, 1990
Decision Date	March 09, 1990
Days to Decision	66 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—

Device Classification

Product Code	LBS — Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl
Device Class	Class I — General Controls
CFR Regulation	21 CFR 862.1475