Cleared Traditional

ROCHE ABUSCREEN ONLINE FOR OPIATES 1000 TEST KIT-2000 NG/ML CUTOFF OLYMPUS AU800 INSTRUMENT APPLICATION

K951319 · Roche Diagnostic Systems, Inc. · Toxicology

Jun 1995

Decision

70d

Days

Class 2

Risk

About This 510(k) Submission

K951319 is an FDA 510(k) clearance for the ROCHE ABUSCREEN ONLINE FOR OPIATES 1000 TEST KIT-2000 NG/ML CUTOFF OLYMPUS AU800 INSTRUMENT APPLICATION, a Radioimmunoassay, Morphine (125-i), Goat Antibody Ammonium Sulfate Sep. (Class II — Special Controls, product code DOE), submitted by Roche Diagnostic Systems, Inc. (Somerville, US). The FDA issued a Cleared decision on June 1, 1995, 70 days after receiving the submission on March 23, 1995. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3640.

Submission Details

510(k) Number	K951319 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 23, 1995
Decision Date	June 01, 1995
Days to Decision	70 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	Statement

Device Classification

Product Code	DOE — Radioimmunoassay, Morphine (125-i), Goat Antibody Ammonium Sulfate Sep.
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 862.3640