RAPID OPIATES TEST STRIP II, RAPID OPIATES TEST CARD II AND DOA MULTIPLE DRUG TEST CARDS (UP TO SIX TESTS)— 510(k) K020716

Name: FDA 510(k) clearance K020716
Creator: U.S. Food and Drug Administration
Published: 2002-05-06

Substantially Equivalent

Rapid Diagnostics, Inc.

FDA 510(k) clearance K020716 for RAPID OPIATES TEST STRIP II, RAPID OPIATES TEST CARD II AND DOA MULTIPLE DRUG TEST CARDS (UP TO SIX TESTS), Substantially Equivalent on 2002-05-06. Applicant: Rapid Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Rapid Diagnostics, Inc.
Product code: Code DJG
Device class: Class 2
Regulation: 21 CFR 862.3650
Advisory panel: Clinical Toxicology
Date received: 2002-03-05
Decision date: 2002-05-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Burlingame, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DJG

view all

K252684 — Labcorp Fentanyl Urine Visual Test2026-01-29
K250741 — Evidence MultiSTAT DOA Urine MultiPlex2026-01-23
K253082 — LZI Buprenorphine II Enzyme Immunoassay2026-01-16
K252520 — SEFRIA Hydrocodone Oral Fluid2025-09-11
K251972 — Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative +1 more2025-08-15

More clearances from Rapid Diagnostics, Inc.

view all

K033566 — MICROMEDIC DRUGS OF ABUSE PANEL TEST (9), CATALOG NUMBER 07RD-70622004-05-17
K003809 — RAPID DRUGS OF ABUSE SINGLE AND MULTIPLE TEST PANELS2001-04-20
K981770 — RAPIDHCG PREGNANCY TEST1998-06-05

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