Cleared Traditional

LIPID PROFILE

K813469 · Bio-Analytics Laboratories, Inc. · Chemistry
Dec 1981
Decision
20d
Days
Class 1
Risk

About This 510(k) Submission

K813469 is an FDA 510(k) clearance for the LIPID PROFILE, a Sulfophosphovanillin, Colorimetry, Total Lipids (Class I — General Controls, product code CFD), submitted by Bio-Analytics Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 31, 1981, 20 days after receiving the submission on December 11, 1981. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1470.

Submission Details

510(k) Number K813469 FDA.gov
FDA Decision Cleared SESE
Date Received December 11, 1981
Decision Date December 31, 1981
Days to Decision 20 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CFD — Sulfophosphovanillin, Colorimetry, Total Lipids
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1470