Cleared Traditional

K811800 - BLUING REAGENT
(FDA 510(k) Clearance)

K811800 · Richard-Allan Medical Ind., Inc. · Hematology device

Aug 1981

Decision

49d

Days

Class 1

Risk

K811800 is an FDA 510(k) clearance for the BLUING REAGENT. 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 August 12, 1981, 49 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	K811800 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 24, 1981
Decision Date	August 12, 1981
Days to Decision	49 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.