COCAINE METABOLITE EIA TEST— 510(k) K915371

Name: FDA 510(k) clearance K915371
Creator: U.S. Food and Drug Administration
Published: 1991-12-18

Substantially Equivalent

Diagnostic Reagents, Inc.

FDA 510(k) clearance K915371 for COCAINE METABOLITE EIA TEST, Substantially Equivalent on 1991-12-18. Applicant: Diagnostic Reagents, Inc.. Device class: 2.

Clearance details

Applicant: Diagnostic Reagents, Inc.
Product code: Code DIO
Device class: Class 2
Regulation: 21 CFR 862.3250
Advisory panel: Clinical Toxicology
Date received: 1991-11-27
Decision date: 1991-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Clara, 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 Diagnostic Reagents, Inc.

view all

K983268 — MODIFICATION OF TRICYCLIC SERUM TOX EIA ASSAY1998-11-18
K983812 — NAPA EIA ASSAY1998-11-16
K983323 — DIGOXIN IMMUNOASSAY1998-11-12
K983280 — VANCOMYCIN EIA ASSAY1998-11-06
K983159 — DRUGS OF ABUSE URINE CALIBRATORS AND CONTROLS1998-11-05

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