Cleared Traditional

N/T PROTEIN CONTROL SL

K964065 · Behring Diagnostics, Inc. · Chemistry
Nov 1996
Decision
27d
Days
Class 1
Risk

About This 510(k) Submission

K964065 is an FDA 510(k) clearance for the N/T PROTEIN CONTROL SL, a Multi-analyte Controls, All Kinds (assayed) (Class I — General Controls, product code JJY), submitted by Behring Diagnostics, Inc. (Westwood, US). The FDA issued a Cleared decision on November 6, 1996, 27 days after receiving the submission on October 10, 1996. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K964065 FDA.gov
FDA Decision Cleared SESE
Date Received October 10, 1996
Decision Date November 06, 1996
Days to Decision 27 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JJY — Multi-analyte Controls, All Kinds (assayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

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