Cleared Traditional

K811796 - FORMAL ALCOHOL
(FDA 510(k) Clearance)

K811796 · Richard-Allan Medical Ind., Inc. · Hematology device

Jul 1981

Decision

34d

Days

Class 1

Risk

K811796 is an FDA 510(k) clearance for the FORMAL ALCOHOL. This device is classified as a General Purpose Reagent (Class I - General Controls, product code PPM).

Submitted by Richard-Allan Medical Ind., Inc. (Mchenry, US). The FDA issued a Cleared decision on July 28, 1981, 34 days after receiving the submission on June 24, 1981.

This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.4010. 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..

Submission Details

510(k) Number	K811796 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 24, 1981
Decision Date	July 28, 1981
Days to Decision	34 days
Submission Type	Traditional
Review Panel	Hematology (HE)
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.