Cleared Traditional

HUMAN PLASMA CONTROL FOR CEA-ROCHE

K822219 · Hoffmann-La Roche, Inc. · Immunology
Dec 1982
Decision
155d
Days
Class 1
Risk

About This 510(k) Submission

K822219 is an FDA 510(k) clearance for the HUMAN PLASMA CONTROL FOR CEA-ROCHE, a Single (specified) Analyte Controls (assayed And Unassayed) (Class I — General Controls, product code JJX), submitted by Hoffmann-La Roche, Inc. (Walker, US). The FDA issued a Cleared decision on December 28, 1982, 155 days after receiving the submission on July 26, 1982. This device falls under the Immunology review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K822219 FDA.gov
FDA Decision Cleared SESE
Date Received July 26, 1982
Decision Date December 28, 1982
Days to Decision 155 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code JJX — Single (specified) Analyte Controls (assayed And Unassayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

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