Cleared Traditional

ICS PAB PREALBUMIN REAGENT TEST KIT

K854811 · Beckman Instruments, Inc. · Immunology
Jan 1986
Decision
52d
Days
Class 1
Risk

About This 510(k) Submission

K854811 is an FDA 510(k) clearance for the ICS PAB PREALBUMIN REAGENT TEST KIT, a Prealbumin, Fitc, Antigen, Antiserum, Control (Class I — General Controls, product code DDS), submitted by Beckman Instruments, Inc. (Fullerton, US). The FDA issued a Cleared decision on January 24, 1986, 52 days after receiving the submission on December 3, 1985. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5060.

Submission Details

510(k) Number K854811 FDA.gov
FDA Decision Cleared SESE
Date Received December 03, 1985
Decision Date January 24, 1986
Days to Decision 52 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code DDS — Prealbumin, Fitc, Antigen, Antiserum, Control
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.5060

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