Cleared Traditional

OPUS PSA TEST SYSTEM

K964595 · Behring Diagnostics, Inc. · Immunology

Jun 1997

Decision

218d

Days

Class 2

Risk

About This 510(k) Submission

K964595 is an FDA 510(k) clearance for the OPUS PSA TEST SYSTEM, a Prostate-specific Antigen (psa) For Management Of Prostate Cancers (Class II — Special Controls, product code LTJ), submitted by Behring Diagnostics, Inc. (Westwood, US). The FDA issued a Cleared decision on June 24, 1997, 218 days after receiving the submission on November 18, 1996. This device falls under the Immunology review panel. Regulated under 21 CFR 866.6010.

Submission Details

510(k) Number	K964595 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 18, 1996
Decision Date	June 24, 1997
Days to Decision	218 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Summary PDF

Device Classification

Product Code	LTJ — Prostate-specific Antigen (psa) For Management Of Prostate Cancers
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.6010