Cleared Traditional

SPRAYFIX

K850916 · Surgipath Medical Industries, Inc. · Pathology

Mar 1985

Decision

20d

Days

Class 1

Risk

About This 510(k) Submission

K850916 is an FDA 510(k) clearance for the SPRAYFIX, a General Purpose Reagent (Class I — General Controls, product code PPM), submitted by Surgipath Medical Industries, Inc. (Grayslake, US). The FDA issued a Cleared decision on March 25, 1985, 20 days after receiving the submission on March 5, 1985. This device falls under the Pathology review panel. Regulated under 21 CFR 864.4010.

Submission Details

510(k) Number	K850916 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 05, 1985
Decision Date	March 25, 1985
Days to Decision	20 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.