Cleared Traditional

CEA CONTROL PLASMA

K812658 · Pacific Hemostasis · Immunology
Sep 1981
Decision
11d
Days
Class 2
Risk

About This 510(k) Submission

K812658 is an FDA 510(k) clearance for the CEA CONTROL PLASMA, a System, Test, Carcinoembryonic Antigen (Class II — Special Controls, product code DHX), submitted by Pacific Hemostasis (Mchenry, US). The FDA issued a Cleared decision on September 29, 1981, 11 days after receiving the submission on September 18, 1981. This device falls under the Immunology review panel. Regulated under 21 CFR 866.6010.

Submission Details

510(k) Number K812658 FDA.gov
FDA Decision Cleared SESE
Date Received September 18, 1981
Decision Date September 29, 1981
Days to Decision 11 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

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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