Cleared Traditional

IMMAGE IMMUNOCHEMISTRY SYSTEM PREALBUMIN (PAB) REAGENT

K964781 · Beckman Instruments, Inc. · Immunology
May 1997
Decision
163d
Days
Class 1
Risk

About This 510(k) Submission

K964781 is an FDA 510(k) clearance for the IMMAGE IMMUNOCHEMISTRY SYSTEM PREALBUMIN (PAB) REAGENT, a Prealbumin, Fitc, Antigen, Antiserum, Control (Class I — General Controls, product code DDS), submitted by Beckman Instruments, Inc. (Brea, US). The FDA issued a Cleared decision on May 9, 1997, 163 days after receiving the submission on November 27, 1996. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5060.

Submission Details

510(k) Number K964781 FDA.gov
FDA Decision Cleared SESE
Date Received November 27, 1996
Decision Date May 09, 1997
Days to Decision 163 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

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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