Cleared Traditional

ABUSCREEN(R) ONLINE(TM) FOR BARBITURATES

K914468 · Roche Diagnostic Systems, Inc. · Toxicology

Oct 1991

Decision

23d

Days

Class 2

Risk

About This 510(k) Submission

K914468 is an FDA 510(k) clearance for the ABUSCREEN(R) ONLINE(TM) FOR BARBITURATES, a Radioimmunoassay, Barbiturate (Class II — Special Controls, product code DKN), submitted by Roche Diagnostic Systems, Inc. (Montclair, US). The FDA issued a Cleared decision on October 30, 1991, 23 days after receiving the submission on October 7, 1991. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3150.

Submission Details

510(k) Number	K914468 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 07, 1991
Decision Date	October 30, 1991
Days to Decision	23 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	Statement