Cleared Traditional

TOMTEC GRAM STAINER DECOLORIZER

K871533 · Remel Co. · Pathology

Apr 1987

Decision

Days

Class 1

Risk

About This 510(k) Submission

K871533 is an FDA 510(k) clearance for the TOMTEC GRAM STAINER DECOLORIZER, a General Purpose Reagent (Class I — General Controls, product code PPM), submitted by Remel Co. (Lenexa, US). The FDA issued a Cleared decision on April 29, 1987, 9 days after receiving the submission on April 20, 1987. This device falls under the Pathology review panel. Regulated under 21 CFR 864.4010.

Submission Details

510(k) Number	K871533 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 20, 1987
Decision Date	April 29, 1987
Days to Decision	9 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.