Cleared Traditional

K850737 - TRANSPORT CULTURE MEDIUM
(FDA 510(k) Clearance)

K850737 · Roseville Medical Laboratoriesu · Pathology device

Mar 1985

Decision

28d

Days

Class 1

Risk

K850737 is an FDA 510(k) clearance for the TRANSPORT CULTURE MEDIUM. This device is classified as a General Purpose Reagent (Class I - General Controls, product code PPM).

Submitted by Roseville Medical Laboratoriesu (Roseville, US). The FDA issued a Cleared decision on March 20, 1985, 28 days after receiving the submission on February 20, 1985.

This device falls under the Pathology 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	K850737 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 20, 1985
Decision Date	March 20, 1985
Days to Decision	28 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.