Cleared Traditional

ACS:CENTAUR PSA2 IMMUNOASSAY

K981839 · Chiron Diagnostics Corp. · Immunology

Aug 1998

Decision

78d

Days

Class 2

Risk

About This 510(k) Submission

K981839 is an FDA 510(k) clearance for the ACS:CENTAUR PSA2 IMMUNOASSAY, a Prostate-specific Antigen (psa) For Management Of Prostate Cancers (Class II — Special Controls, product code LTJ), submitted by Chiron Diagnostics Corp. (Medfield, US). The FDA issued a Cleared decision on August 12, 1998, 78 days after receiving the submission on May 26, 1998. This device falls under the Immunology review panel. Regulated under 21 CFR 866.6010.

Submission Details

510(k) Number	K981839 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 26, 1998
Decision Date	August 12, 1998
Days to Decision	78 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