Cleared Traditional

POTASSIUM HYDROXIDE 10% W/V

K863550 · Reagent Laboratory, Inc. · Chemistry

Oct 1986

Decision

20d

Days

Class 1

Risk

About This 510(k) Submission

K863550 is an FDA 510(k) clearance for the POTASSIUM HYDROXIDE 10% W/V, a General Purpose Reagent (Class I — General Controls, product code PPM), submitted by Reagent Laboratory, Inc. (Louisville, US). The FDA issued a Cleared decision on October 2, 1986, 20 days after receiving the submission on September 12, 1986. This device falls under the Chemistry review panel. Regulated under 21 CFR 864.4010.

Submission Details

510(k) Number	K863550 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 12, 1986
Decision Date	October 02, 1986
Days to Decision	20 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—

Device Classification

Product Code	PPM — General Purpose Reagent
Device Class	Class I — General Controls
CFR Regulation	21 CFR 864.4010
Definition	A General Purpose Reagent Is A Chemical Reagent That Has General Laboratory Application, That Is Used To Collect, Prepare, And Examine Specimens From The Human Body For Diagnostic Purposes, And That Is Not Labeled Or Otherwise Intended For A Specific Diagnostic Application. It May Be Either An Individual Substance, Or Multiple Substances Reformulated, Which, When Combined With Or Used In Conjunction With An Appropriate Analyte Specific Reagent (asr) And Other General Purpose Reagents, Is Part Of A Diagnostic Test Procedure Or System Constituting A Finished In Vitro Diagnostic (ivd) Test.