Cleared Traditional

DIMENSION C4 FLEX REAGENT CARTRIDGE

K994293 · Dade Behring, Inc. · Immunology
Mar 2000
Decision
71d
Days
Class 2
Risk

About This 510(k) Submission

K994293 is an FDA 510(k) clearance for the DIMENSION C4 FLEX REAGENT CARTRIDGE, a Complement C4, Antigen, Antiserum, Control (Class II — Special Controls, product code DBI), submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on March 1, 2000, 71 days after receiving the submission on December 21, 1999. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5240.

Submission Details

510(k) Number K994293 FDA.gov
FDA Decision Cleared SESE
Date Received December 21, 1999
Decision Date March 01, 2000
Days to Decision 71 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code DBI — Complement C4, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5240

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