Cleared Traditional

IMMUNOTECH CHOLESTEROL TEST

K897036 · Immunotech Corp. · Chemistry
Mar 1990
Decision
78d
Days
Class 1
Risk

About This 510(k) Submission

K897036 is an FDA 510(k) clearance for the IMMUNOTECH CHOLESTEROL TEST, a Enzymatic Esterase--oxidase, Cholesterol (Class I — General Controls, product code CHH), submitted by Immunotech Corp. (Boston, US). The FDA issued a Cleared decision on March 6, 1990, 78 days after receiving the submission on December 18, 1989. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1175.

Submission Details

510(k) Number K897036 FDA.gov
FDA Decision Cleared SESE
Date Received December 18, 1989
Decision Date March 06, 1990
Days to Decision 78 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CHH — Enzymatic Esterase--oxidase, Cholesterol
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1175

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