Cleared Traditional

K973244 - ACTIVE PSA IRMA (DSL-9700)
(FDA 510(k) Clearance)

K973244 · Diagnostic Systems Laboratories, Inc. · Immunology

Aug 1998

Decision

339d

Days

Class 2

Risk

K973244 is an FDA 510(k) clearance for the ACTIVE PSA IRMA (DSL-9700). This device is classified as a Prostate-specific Antigen (psa) For Management Of Prostate Cancers (Class II — Special Controls, product code LTJ).

Submitted by Diagnostic Systems Laboratories, Inc. (Webster, US). The FDA issued a Cleared decision on August 3, 1998, 339 days after receiving the submission on August 29, 1997.

This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.6010.

Submission Details

510(k) Number	K973244 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 29, 1997
Decision Date	August 03, 1998
Days to Decision	339 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