Cleared Traditional

ELECSYS PSA, MODEL 2010

K982949 · Boehringer Mannheim Corp. · Immunology

Oct 1998

Decision

67d

Days

Class 2

Risk

About This 510(k) Submission

K982949 is an FDA 510(k) clearance for the ELECSYS PSA, MODEL 2010, a Prostate-specific Antigen (psa) For Management Of Prostate Cancers (Class II — Special Controls, product code LTJ), submitted by Boehringer Mannheim Corp. (Indianapolis,, US). The FDA issued a Cleared decision on October 27, 1998, 67 days after receiving the submission on August 21, 1998. This device falls under the Immunology review panel. Regulated under 21 CFR 866.6010.

Submission Details

510(k) Number	K982949 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 21, 1998
Decision Date	October 27, 1998
Days to Decision	67 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