Cleared Traditional

CEA-IMMERSIBLE SEPARATOR

K781043 · Millipore Corp. · Immunology
Sep 1978
Decision
87d
Days
Class 1
Risk

About This 510(k) Submission

K781043 is an FDA 510(k) clearance for the CEA-IMMERSIBLE SEPARATOR, a Unit, Filter, Membrane (Class I — General Controls, product code JRL), submitted by Millipore Corp. (Mchenry, US). The FDA issued a Cleared decision on September 15, 1978, 87 days after receiving the submission on June 20, 1978. This device falls under the Immunology review panel. Regulated under 21 CFR 862.2050.

Submission Details

510(k) Number K781043 FDA.gov
FDA Decision Cleared SESE
Date Received June 20, 1978
Decision Date September 15, 1978
Days to Decision 87 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code JRL — Unit, Filter, Membrane
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2050