Cleared Traditional

K871260 - CHOLESTEROL DETERMINATION
(FDA 510(k) Clearance)

K871260 · Biochemical Trade, Inc. · Chemistry

Apr 1987

Decision

13d

Days

Class 1

Risk

K871260 is an FDA 510(k) clearance for the CHOLESTEROL DETERMINATION. This device is classified as a Enzymatic Esterase--oxidase, Cholesterol (Class I — General Controls, product code CHH).

Submitted by Biochemical Trade, Inc. (Miami, US). The FDA issued a Cleared decision on April 13, 1987, 13 days after receiving the submission on March 31, 1987.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1175.

Submission Details

510(k) Number	K871260 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 31, 1987
Decision Date	April 13, 1987
Days to Decision	13 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—