Cleared Traditional

K972853 - CHOLESTEROL RAPID LIQUID REAGENT
(FDA 510(k) Clearance)

K972853 · Reagents Applications, Inc. · Chemistry

Sep 1997

Decision

89d

Days

Class 1

Risk

K972853 is an FDA 510(k) clearance for the CHOLESTEROL RAPID LIQUID REAGENT, a Enzymatic Esterase--oxidase, Cholesterol (Class I — General Controls, product code CHH), submitted by Reagents Applications, Inc. (San Diego, US). The FDA issued a Cleared decision on September 24, 1997, 89 days after receiving the submission on June 27, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1175.

Submission Details

510(k) Number	K972853 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 27, 1997
Decision Date	September 24, 1997
Days to Decision	89 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Statement