DBEST COCAINE TEST KIT— 510(k) K983191

Substantially Equivalent

Ameritek, Inc.

FDA 510(k) clearance K983191 for DBEST COCAINE TEST KIT, Substantially Equivalent on 1998-11-18. Applicant: Ameritek, Inc.. Device class: 2.

Clearance details

Applicant: Ameritek, Inc.
Product code: Product code DIO
Device class: Class 2
Regulation: 21 CFR 862.3250
Advisory panel: Clinical Toxicology
Date received: 1998-09-11
Decision date: 1998-11-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seattle, WA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DIO

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 Ameritek, Inc.

K001215 — DBEST HCG 2 IU/ML TEST KIT2000-06-22
K990873 — DBEST URINARY TRACT INFECTION TEST KIT FOR HOME-USE1999-09-01
K990681 — DBSET MULTIDRUG SCREEN TEST KIT1999-07-15
K984269 — DBEST OCCULT BLOOD TEST KIT1999-05-11
K983188 — DBEST TETRAHYDROCANNABINOL TEST KIT1998-11-18

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