Automates Coma Cocaine Metabolite Assay

FDA 510(k) K921834 · Serex, Inc.

Substantially Equivalent

510(k) numberK921834

Submission

Device name
Automates Coma Cocaine Metabolite Assay
Applicant
Serex, Inc.
Maywood, NJ, US
Received
April 16, 1992
Decision date
June 15, 1992
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DIO – Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Device class
Class II (moderate risk)
Regulation
21 CFR 862.3250
Specialty
Clinical Toxicology

Other 510(k)s with product code DIO

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K213211Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM)…DIO · Traditional Carolina Liquid Chemistries Corp.01/27/2022SE
K211973DRI Cocaine Metabolite AssayDIO · Traditional Microgenics Corporation09/24/2021SE
K191638Pointe Scientific Cocaine Metabolite Enzyme ImmunoassayDIO · Traditional Medtest DX03/12/2020SE
K181499DRI Cocaine Metabolite AssayDIO · Traditional Microgenics Corporation07/06/2018SE
K170293Emit II Plus Cocaine Metabolite AssayDIO · Traditional Siemens Healthcare Diagnostics, Inc.10/25/2017SE
K163570Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM)DIO · Traditional Carolina Liquid Chemistries Corporation08/15/2017SE
K162395MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test CupDIO · Special Mp Biomedicals, LLC06/02/2017SE
K152232Quest Diagnostics HairCheck-DT (Cocaine)DIO · Traditional Quest Diagnostics Incorporated11/18/2016SE
K161214Wondfo Amphetamine Urine Test AMP 500 (Cup, Dipcard), Wondfo Cocaine Urine Test COC…DIO · Traditional Guangzhou Wondfo Biotech Co., Ltd.06/27/2016SE
K153646SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test…DIO · Traditional Safecare Biotech (Hangzhou) Co., Ltd.03/18/2016SE

More from Safecare Biotech (Hangzhou) Co., Ltd.

510(k)DeviceDecision
K923314Automates Coma Plus Cocaine Metabolite AssayJXO · Traditional 08/24/1992SE
K901333BETA-2 Microglobulin EiaJZG · Traditional 04/02/1990SE
K895043Coma Cocaine Metabolite Assay (Eia)DIO · Traditional 11/08/1989SE
K890694BETA-2 Microglobulin EiaJZG · Traditional 03/16/1989SE

Questions and answers

When was Automates Coma Cocaine Metabolite Assay cleared by the FDA?

Automates Coma Cocaine Metabolite Assay (K921834) received a 510(k) decision of Substantially Equivalent on June 15, 1992, 60 days after the submission was received.

What is the product code of K921834?

The FDA product code is DIO – Enzyme Immunoassay, Cocaine And Cocaine Metabolites, a Class II (moderate risk) device regulated under 21 CFR 862.3250.