Cleared Traditional

N LATEX B2-MICROGLOBULIN REAGENT

K955596 · Behring Diagnostics, Inc. · Immunology
Oct 1996
Decision
300d
Days
Class 2
Risk

About This 510(k) Submission

K955596 is an FDA 510(k) clearance for the N LATEX B2-MICROGLOBULIN REAGENT, a System, Test, Beta-2-microglobulin Immunological (Class II — Special Controls, product code JZG), submitted by Behring Diagnostics, Inc. (Westwood, US). The FDA issued a Cleared decision on October 3, 1996, 300 days after receiving the submission on December 8, 1995. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5630.

Submission Details

510(k) Number K955596 FDA.gov
FDA Decision Cleared SESE
Date Received December 08, 1995
Decision Date October 03, 1996
Days to Decision 300 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code JZG — System, Test, Beta-2-microglobulin Immunological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5630

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