MIRCOLINE SCREEN FOR COCAINE— 510(k) K911652

Name: FDA 510(k) clearance K911652
Creator: U.S. Food and Drug Administration
Published: 1991-05-15

Substantially Equivalent

Drug Screening Systems, Inc.

FDA 510(k) clearance K911652 for MIRCOLINE SCREEN FOR COCAINE, Substantially Equivalent on 1991-05-15. Applicant: Drug Screening Systems, Inc.. Device class: 2.

Clearance details

Applicant: Drug Screening Systems, Inc.
Product code: Code DIO
Device class: Class 2
Regulation: 21 CFR 862.3250
Advisory panel: Clinical Toxicology
Date received: 1991-04-12
Decision date: 1991-05-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Blackwood, 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 Drug Screening Systems, Inc.

view all

K945829 — MICROLINE SCREEN FOR BENZODIAZEPINE1995-01-25
K935052 — MICROLINE SCREEN FOR AMPHETAMINE1994-09-16
K933480 — MICROLINE SCREEN FOR BARBITURATES1993-10-29
K921651 — MICROLINE SCREEN FOR PHENCYCLIDINE1992-07-08
K914915 — MICROLINE SCREEN FOR CANNABINOID1992-01-22

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