COCAINE DIPSTICK TEST, MODEL D747-A— 510(k) K010239

Name: FDA 510(k) clearance K010239
Creator: U.S. Food and Drug Administration
Published: 2001-06-25

Substantially Equivalent

Teco Diagnostics

FDA 510(k) clearance K010239 for COCAINE DIPSTICK TEST, MODEL D747-A, Substantially Equivalent on 2001-06-25. Applicant: Teco Diagnostics. Device class: 2.

Clearance details

Applicant: Teco Diagnostics
Product code: Code DIO
Device class: Class 2
Regulation: 21 CFR 862.3250
Advisory panel: Clinical Toxicology
Date received: 2001-01-25
Decision date: 2001-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Anaheim, CA, 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 Teco Diagnostics

view all

K170118 — Scanostics UTI Check Application Test System2017-09-21
K141289 — TC-THUNDERBOLT AUTOMATED URINE ANALYZER SYSTEM AND TC-THUNDERBOLT URS-10 STRIPS2015-07-24
K131600 — URS-2GP (GLUCOSE PROTEIN) URINE STRIPS2014-05-29
K111206 — TECO DIAGNOSTICS SALIVA ALCOHOL TEST2011-10-04
K100024 — TECO DIAGNOSTICS UTI DETECTION STRIPS2011-02-17

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