Cleared Traditional

ROCHE ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE (HIGH CUT-OFF)

K935055 · Roche Diagnostic Systems, Inc. · Toxicology

Aug 1994

Decision

293d

Days

Class 2

Risk

About This 510(k) Submission

K935055 is an FDA 510(k) clearance for the ROCHE ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE (HIGH CUT-OFF), a Radioimmunoassay, Morphine (125-i), Goat Antibody Ammonium Sulfate Sep. (Class II — Special Controls, product code DOE), submitted by Roche Diagnostic Systems, Inc. (Branchburg, US). The FDA issued a Cleared decision on August 9, 1994, 293 days after receiving the submission on October 20, 1993. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3640.

Submission Details

510(k) Number	K935055 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 20, 1993
Decision Date	August 09, 1994
Days to Decision	293 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