Cleared Traditional

IMMAGE IMMUNOCHEMISTRY SYSTEM COMPLEMENTC3 (C3) AND COMPLEMENTC4 (C4) REAGENT

K964842 · Beckman Instruments, Inc. · Immunology
Jun 1997
Decision
190d
Days
Class 2
Risk

About This 510(k) Submission

K964842 is an FDA 510(k) clearance for the IMMAGE IMMUNOCHEMISTRY SYSTEM COMPLEMENTC3 (C3) AND COMPLEMENTC4 (C4) REAGENT, a Complement C3, Antigen, Antiserum, Control (Class II — Special Controls, product code CZW), submitted by Beckman Instruments, Inc. (Brea, US). The FDA issued a Cleared decision on June 11, 1997, 190 days after receiving the submission on December 3, 1996. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5240.

Submission Details

510(k) Number K964842 FDA.gov
FDA Decision Cleared SESE
Date Received December 03, 1996
Decision Date June 11, 1997
Days to Decision 190 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code CZW — Complement C3, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5240

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