Cleared Traditional

SYVA EMIT II PLUS COCAINE METABOLITE ASSAY, MODEL 9H029UL

K993988 · Syva Co. · Toxicology
Jan 2000
Decision
64d
Days
Class 2
Risk

About This 510(k) Submission

K993988 is an FDA 510(k) clearance for the SYVA EMIT II PLUS COCAINE METABOLITE ASSAY, MODEL 9H029UL, a Enzyme Immunoassay, Cocaine And Cocaine Metabolites (Class II — Special Controls, product code DIO), submitted by Syva Co. (San Jose, US). The FDA issued a Cleared decision on January 27, 2000, 64 days after receiving the submission on November 24, 1999. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3250.

Submission Details

510(k) Number K993988 FDA.gov
FDA Decision Cleared SESE
Date Received November 24, 1999
Decision Date January 27, 2000
Days to Decision 64 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code DIO — Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3250

Similar Devices — DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites

All 144
Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test System
K213211 · Carolina Liquid Chemistries Corp. · Jan 2022
DRI Cocaine Metabolite Assay
K211973 · Microgenics Corporation · Sep 2021
Pointe Scientific Cocaine Metabolite Enzyme Immunoassay
K191638 · Medtest DX · Mar 2020
DRI Cocaine Metabolite Assay
K181499 · Microgenics Corporation · Jul 2018
Emit II Plus Cocaine Metabolite Assay
K170293 · Siemens Healthcare Diagnostics, Inc. · Oct 2017
Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM)
K163570 · Carolina Liquid Chemistries Corporation · Aug 2017