Cleared Traditional

VIDAS TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA), MODEL 30 428

K010550 · bioMerieux, Inc. · Immunology

Apr 2001

Decision

57d

Days

Class 2

Risk

About This 510(k) Submission

K010550 is an FDA 510(k) clearance for the VIDAS TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA), MODEL 30 428, a Prostate-specific Antigen (psa) For Management Of Prostate Cancers (Class II — Special Controls, product code LTJ), submitted by bioMerieux, Inc. (Hazelwood, US). The FDA issued a Cleared decision on April 24, 2001, 57 days after receiving the submission on February 26, 2001. This device falls under the Immunology review panel. Regulated under 21 CFR 866.6010.

Submission Details

510(k) Number	K010550 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 26, 2001
Decision Date	April 24, 2001
Days to Decision	57 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