Micromedic Crackpot Ria Kit

FDA 510(k) K880674 · Icn Micromedic Systems

Substantially Equivalent

510(k) numberK880674

Submission

Device name
Micromedic Crackpot Ria Kit
Applicant
Icn Micromedic Systems
Horsham, PA, US
Received
February 19, 1988
Decision date
October 6, 1988
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KLN – Radioimmunoassay, Cocaine Metabolite
Device class
Class II (moderate risk)
Regulation
21 CFR 862.3250
Specialty
Clinical Toxicology

Other 510(k)s with product code KLN

510(k)DeviceApplicantDecision
K010868Psychemedics Ria Cocaine AssayKLN · Traditional Psychemedics Corp.11/06/2001SE
K913867Urine Cocaine Metabolite Direct Ria Kit (I-125)KLN · Traditional Immunalysis Corporation09/19/1991SE
K913722Abuscreen(R) Radioimmun for Cocaine MetaboliteKLN · Traditional Roche Diagnostic Systems, Inc.09/10/1991SE
K912756Abuscreen Radioimmunoassay for Cocaine MetaboliteKLN · Traditional Roche Diagnostic Systems, Inc.07/26/1991SE
K910123Target Cocaine Metabolite-VKLN · Traditional V-Tech, Inc.03/19/1991SE
K910122Target Cocaine Metabolite-RKLN · Traditional V-Tech, Inc.03/19/1991SE
K910044Milenia Cocaine MetaboliteKLN · Traditional Diagnostic Products Corp.02/13/1991SE
K905730Abuscreen Ontrak for Cocaine (200NG/ML)KLN · Traditional Roche Diagnostic Systems, Inc.01/15/1991SE
K904995Abuscreen Online TM for Cocaine MetaboliteKLN · Traditional Roche Diagnostic Systems, Inc.11/28/1990SE
K871549Resub. Urine Cocaine Meta. Direct Ria Kit [I-125]KLN · Traditional Immunalysis Corporation06/16/1987SE

More from Immunalysis Corporation

510(k)DeviceDecision
K884269Sample Identification Station Model 38010JJJ · Traditional 01/09/1989SE
K883746Micromedic Ferritin Irma KitDBF · Traditional 10/27/1988SE
K881102Micromedic Morphine Ria KitDOE · Traditional 06/24/1988SE

Questions and answers

When was Micromedic Crackpot Ria Kit cleared by the FDA?

Micromedic Crackpot Ria Kit (K880674) received a 510(k) decision of Substantially Equivalent on October 6, 1988, 230 days after the submission was received.

What is the product code of K880674?

The FDA product code is KLN – Radioimmunoassay, Cocaine Metabolite, a Class II (moderate risk) device regulated under 21 CFR 862.3250.