Cleared Traditional

N RHEUMATOLOGY STANDARD SL

K964527 · Behring Diagnostics, Inc. · Immunology
Jan 1997
Decision
64d
Days
Class 2
Risk

About This 510(k) Submission

K964527 is an FDA 510(k) clearance for the N RHEUMATOLOGY STANDARD SL, a Calibrator, Multi-analyte Mixture (Class II — Special Controls, product code JIX), submitted by Behring Diagnostics, Inc. (Westwood, US). The FDA issued a Cleared decision on January 15, 1997, 64 days after receiving the submission on November 12, 1996. This device falls under the Immunology review panel. Regulated under 21 CFR 862.1150.

Submission Details

510(k) Number K964527 FDA.gov
FDA Decision Cleared SESE
Date Received November 12, 1996
Decision Date January 15, 1997
Days to Decision 64 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code JIX — Calibrator, Multi-analyte Mixture
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1150

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