Micromedic Morphine Ria Kit

FDA 510(k) K881102 · Icn Micromedic Systems

Substantially Equivalent

510(k) numberK881102

Submission

Device name
Micromedic Morphine Ria Kit
Applicant
Icn Micromedic Systems
Horsham, PA, US
Received
March 15, 1988
Decision date
June 24, 1988
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
DOE – Radioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep.
Device class
Class II (moderate risk)
Regulation
21 CFR 862.3640
Specialty
Clinical Toxicology

Other 510(k)s with product code DOE

510(k)DeviceApplicantDecision
K010080Instant-View Morphine (2000) Urine Cassette TestDOE · Traditional Alfa Scientific Designs, Inc.05/29/2001SE
K010079Instant-View Morphine (2000) Urine Dip Strip TestDOE · Traditional Alfa Scientific Designs, Inc.05/29/2001SE
K011011Livesure Morphine Screen TestDOE · Traditional Pan Probe Biotech, Inc.04/13/2001SE
K002418Branan Medical Corporation Monitect Morphine 300 Drug Screen Test, Model 133C and 133DDOE · Traditional Branan Medical Corporation11/22/2000SE
K951319Roche Abuscreen Online for Opiates 1000 Test KIT-2000 Ng/Ml Cutoff Olympus AU800…DOE · Traditional Roche Diagnostic Systems, Inc.06/01/1995SE
K935055Roche Abuscreen Radioimmunoassay for Morphine (High Cut-Off)DOE · Traditional Roche Diagnostic Systems, Inc.08/09/1994SE
K933572Urine Heroin/Morphine Direct Ria Kit (I-125)DOE · Traditional Immunalysis Corporation04/06/1994SE
K863913The DPC Coat-A-Count Serum Morphine Ria KitDOE · Traditional Diagnostic Products Corp.03/19/1987SE
K864168Morphine Roche (R) Eia TestDOE · Traditional Roche Diagnostic Systems, Inc.03/16/1987SE
K830462Abuscreen Radioummunoassay--UrineDOE · Traditional Hoffmann-La Roche, Inc.03/24/1983SE

More from Hoffmann-La Roche, Inc.

510(k)DeviceDecision
K884269Sample Identification Station Model 38010JJJ · Traditional 01/09/1989SE
K883746Micromedic Ferritin Irma KitDBF · Traditional 10/27/1988SE
K880674Micromedic Crackpot Ria KitKLN · Traditional 10/06/1988SE

Questions and answers

When was Micromedic Morphine Ria Kit cleared by the FDA?

Micromedic Morphine Ria Kit (K881102) received a 510(k) decision of Substantially Equivalent on June 24, 1988, 101 days after the submission was received.

What is the product code of K881102?

The FDA product code is DOE – Radioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep., a Class II (moderate risk) device regulated under 21 CFR 862.3640.