Cleared Traditional

HDL CHOLESTEROL, PRODUCT NO'S 124-01, CH102-01

K991665 · A.P. Total Care, Inc. · Chemistry

Aug 1999

Decision

88d

Days

Class 1

Risk

About This 510(k) Submission

K991665 is an FDA 510(k) clearance for the HDL CHOLESTEROL, PRODUCT NO'S 124-01, CH102-01, a Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl (Class I — General Controls, product code LBS), submitted by A.P. Total Care, Inc. (Bridgeport, US). The FDA issued a Cleared decision on August 10, 1999, 88 days after receiving the submission on May 14, 1999. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1475.

Submission Details

510(k) Number	K991665 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 14, 1999
Decision Date	August 10, 1999
Days to Decision	88 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Statement

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