ABUSCREEN RADIOUMMUNOASSAY-METHAQUALONE— 510(k) K830461

Name: FDA 510(k) clearance K830461
Creator: U.S. Food and Drug Administration
Published: 1983-03-24

Substantially Equivalent

Hoffmann-La Roche, Inc.

FDA 510(k) clearance K830461 for ABUSCREEN RADIOUMMUNOASSAY-METHAQUALONE, Substantially Equivalent on 1983-03-24. Applicant: Hoffmann-La Roche, Inc.. Device class: 2.

Clearance details

Applicant: Hoffmann-La Roche, Inc.
Product code: Code KXS
Device class: Class 2
Regulation: 21 CFR 862.3630
Advisory panel: Clinical Toxicology
Date received: 1983-02-15
Decision date: 1983-03-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KXS

view all

K011164 — MODIFICATION TO THE EMIT II PLUS METHAQUALONE ASSAY, MODEL OSR9Q2292001-05-10
K993986 — SYVA EMIT II PLUS METHAQUALONE ASSAY, MODEL 9Q029UL/9Q129UL2000-01-27
K955676 — SYNCHRON SYSTEMS METHAQUALONE REAGENT1996-03-04
K945187 — ROCHE ABUSCREEN ONLINE FOR METHAQUALONE1995-04-05
K940123 — METHAQUALONE ENZYME IMMUNOASSAY1994-05-03

More clearances from Hoffmann-La Roche, Inc.

view all

K850727 — BHCG-ROCHE EIA1985-06-25
K831694 — RENAK1983-07-19
K830460 — ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE1983-03-24
K830462 — ABUSCREEN RADIOUMMUNOASSAY--URINE1983-03-24
K830480 — ABUSCREEN RADIOIMMUNOASSAY-COCAINE META1983-03-24

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