AUTOMATES COMA COCAINE METABOLITE ASSAY— 510(k) K921834

Name: FDA 510(k) clearance K921834
Creator: U.S. Food and Drug Administration
Published: 1992-06-15

Substantially Equivalent

Serex, Inc.

FDA 510(k) clearance K921834 for AUTOMATES COMA COCAINE METABOLITE ASSAY, Substantially Equivalent on 1992-06-15. Applicant: Serex, Inc.. Device class: 2.

Clearance details

Applicant: Serex, Inc.
Product code: Code DIO
Device class: Class 2
Regulation: 21 CFR 862.3250
Advisory panel: Clinical Toxicology
Date received: 1992-04-16
Decision date: 1992-06-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Maywood, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DIO

view all

K213211 — Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test System2022-01-27
K211973 — DRI Cocaine Metabolite Assay2021-09-24
K191638 — Pointe Scientific Cocaine Metabolite Enzyme Immunoassay2020-03-12
K181499 — DRI Cocaine Metabolite Assay2018-07-06
K170293 — Emit II Plus Cocaine Metabolite Assay2017-10-25

More clearances from Serex, Inc.

view all

K923314 — AUTOMATES COMA PLUS COCAINE METABOLITE ASSAY1992-08-24
K901333 — BETA-2 MICROGLOBULIN EIA1990-04-02
K895043 — COMA COCAINE METABOLITE ASSAY (EIA)1989-11-08
K890694 — BETA-2 MICROGLOBULIN EIA1989-03-16

Data sourced from openFDA. This site is unofficial and independent of the FDA.