Cleared Traditional

VOLU-SOL TAP WATER SUBSTITUTE

K822037 · Volu Sol Medical Industries · Pathology

Aug 1982

Decision

22d

Days

Class 1

Risk

About This 510(k) Submission

K822037 is an FDA 510(k) clearance for the VOLU-SOL TAP WATER SUBSTITUTE, a General Purpose Reagent (Class I — General Controls, product code PPM), submitted by Volu Sol Medical Industries (Mchenry, US). The FDA issued a Cleared decision on August 3, 1982, 22 days after receiving the submission on July 12, 1982. This device falls under the Pathology review panel. Regulated under 21 CFR 864.4010.

Submission Details

510(k) Number	K822037 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 12, 1982
Decision Date	August 03, 1982
Days to Decision	22 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.