Cleared Traditional

ELECSYS CEA ON THE ELECSYS 1010

K980887 · Boehringer Mannheim Corp. · Immunology
Jun 1998
Decision
112d
Days
Class 2
Risk

About This 510(k) Submission

K980887 is an FDA 510(k) clearance for the ELECSYS CEA ON THE ELECSYS 1010, a System, Test, Carcinoembryonic Antigen (Class II — Special Controls, product code DHX), submitted by Boehringer Mannheim Corp. (Pleasanton, US). The FDA issued a Cleared decision on June 29, 1998, 112 days after receiving the submission on March 9, 1998. This device falls under the Immunology review panel. Regulated under 21 CFR 866.6010.

Submission Details

510(k) Number K980887 FDA.gov
FDA Decision Cleared SESE
Date Received March 09, 1998
Decision Date June 29, 1998
Days to Decision 112 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code DHX — System, Test, Carcinoembryonic Antigen
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.6010

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