MODIFICATION TO ABUSCREEN ONLINE FOR AMPHETAMINES— 510(k) K983699

Name: FDA 510(k) clearance K983699
Creator: U.S. Food and Drug Administration
Published: 1998-12-11

Substantially Equivalent

Roche Diagnostic Systems, Inc.

FDA 510(k) clearance K983699 for MODIFICATION TO ABUSCREEN ONLINE FOR AMPHETAMINES, Substantially Equivalent on 1998-12-11. Applicant: Roche Diagnostic Systems, Inc.. Device class: 2.

Clearance details

Applicant: Roche Diagnostic Systems, Inc.
Product code: Code DKZ
Device class: Class 2
Regulation: 21 CFR 862.3100
Advisory panel: Clinical Toxicology
Date received: 1998-10-21
Decision date: 1998-12-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Somerville, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DKZ

view all

K240670 — DRI Ecstasy Plus Assay2024-10-30
K233019 — AllTest Multi-Drug Rapid Test Cup +3 more2023-12-13
K231137 — Xenta Drug Screen Cup, Xenta Drug Screen Dipcard2023-05-19
K200363 — Quidel Triage® TOX Drug Screen, 946002020-03-11
K191099 — Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel2019-10-03

More clearances from Roche Diagnostic Systems, Inc.

view all

K983698 — MODIFICATION TO ABUSCREEN ONLINE BARBITURATES1999-05-03
K983702 — MODIFICATION TO ABUSCREEN ONLINE FOR BENZOIDIAZEPINES1999-02-11
K983704 — MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINE1999-02-10
K983555 — ABUSCREEN ONLINE BENZ 200 CALIBRATORS1998-12-15
K983556 — ABUSCREEN ONLINE BENZ 300 CALIBRATORS1998-12-15

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