Cleared Traditional

100%, 95%, 80% & 70% DEHYDRANT CUSTOM BLEND NO. 2

K861890 · Richard-Allan Medical Ind., Inc. · Pathology

Jun 1986

Decision

18d

Days

Class 1

Risk

About This 510(k) Submission

K861890 is an FDA 510(k) clearance for the 100%, 95%, 80% & 70% DEHYDRANT CUSTOM BLEND NO. 2, a General Purpose Reagent (Class I — General Controls, product code PPM), submitted by Richard-Allan Medical Ind., Inc. (Richland, US). The FDA issued a Cleared decision on June 3, 1986, 18 days after receiving the submission on May 16, 1986. This device falls under the Pathology review panel. Regulated under 21 CFR 864.4010.

Submission Details

510(k) Number	K861890 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 16, 1986
Decision Date	June 03, 1986
Days to Decision	18 days
Submission Type	Traditional
Review Panel	Pathology (PA)
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.