Cleared Traditional

ACCESS(R) PSA REAGENTS ON THE ACCESS(R) IMMUNOASSAY ANALYZER 33220, 33225, 33229

K974816 · Beckman Instruments, Inc. · Immunology

Feb 1998

Decision

59d

Days

Class 2

Risk

About This 510(k) Submission

K974816 is an FDA 510(k) clearance for the ACCESS(R) PSA REAGENTS ON THE ACCESS(R) IMMUNOASSAY ANALYZER 33220, 33225, 33229, a Prostate-specific Antigen (psa) For Management Of Prostate Cancers (Class II — Special Controls, product code LTJ), submitted by Beckman Instruments, Inc. (Chaska, US). The FDA issued a Cleared decision on February 20, 1998, 59 days after receiving the submission on December 23, 1997. This device falls under the Immunology review panel. Regulated under 21 CFR 866.6010.

Submission Details

510(k) Number	K974816 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 23, 1997
Decision Date	February 20, 1998
Days to Decision	59 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