Cleared Traditional

MODIFICATION OF OPUS FERRITIN TEST SYSTEM

K973202 · Behring Diagnostics, Inc. · Immunology
Sep 1997
Decision
66d
Days
Class 2
Risk

About This 510(k) Submission

K973202 is an FDA 510(k) clearance for the MODIFICATION OF OPUS FERRITIN TEST SYSTEM, a Ferritin, Antigen, Antiserum, Control (Class II — Special Controls, product code DBF), submitted by Behring Diagnostics, Inc. (Westwood, US). The FDA issued a Cleared decision on September 12, 1997, 66 days after receiving the submission on July 8, 1997. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5340.

Submission Details

510(k) Number K973202 FDA.gov
FDA Decision Cleared SESE
Date Received July 08, 1997
Decision Date September 12, 1997
Days to Decision 66 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code DBF — Ferritin, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5340

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