Cleared Traditional

PROSTATE SPECIFIC ANTIGEN METHOD

K973101 · Dade Chemistry Systems, Inc. · Immunology

Sep 1997

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K973101 is an FDA 510(k) clearance for the PROSTATE SPECIFIC ANTIGEN METHOD, a Prostate-specific Antigen (psa) For Management Of Prostate Cancers (Class II — Special Controls, product code LTJ), submitted by Dade Chemistry Systems, Inc. (Newark, US). The FDA issued a Cleared decision on September 18, 1997, 30 days after receiving the submission on August 19, 1997. This device falls under the Immunology review panel. Regulated under 21 CFR 866.6010.

Submission Details

510(k) Number	K973101 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 19, 1997
Decision Date	September 18, 1997
Days to Decision	30 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