Cleared Traditional

IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN A-1 REAGENT (APA)/ IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN B REAGENT

K964010 · Beckman Instruments, Inc. · Immunology
Feb 1997
Decision
126d
Days
Class 1
Risk

About This 510(k) Submission

K964010 is an FDA 510(k) clearance for the IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN A-1 REAGENT (APA)/ IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN B REAGENT, a Apolipoproteins (Class I — General Controls, product code MSJ), submitted by Beckman Instruments, Inc. (Brea, US). The FDA issued a Cleared decision on February 10, 1997, 126 days after receiving the submission on October 7, 1996. This device falls under the Immunology review panel. Regulated under 21 CFR 862.1475.

Submission Details

510(k) Number K964010 FDA.gov
FDA Decision Cleared SESE
Date Received October 07, 1996
Decision Date February 10, 1997
Days to Decision 126 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code MSJ — Apolipoproteins
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1475

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