Cleared Traditional

OPUS MYOGLOBIN CONTROLS

K962841 · Behring Diagnostics, Inc. · Immunology
Aug 1996
Decision
24d
Days
Class 1
Risk

About This 510(k) Submission

K962841 is an FDA 510(k) clearance for the OPUS MYOGLOBIN CONTROLS, a Single (specified) Analyte Controls (assayed And Unassayed) (Class I — General Controls, product code JJX), submitted by Behring Diagnostics, Inc. (Westwood, US). The FDA issued a Cleared decision on August 15, 1996, 24 days after receiving the submission on July 22, 1996. This device falls under the Immunology review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K962841 FDA.gov
FDA Decision Cleared SESE
Date Received July 22, 1996
Decision Date August 15, 1996
Days to Decision 24 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code JJX — Single (specified) Analyte Controls (assayed And Unassayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

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