Cleared Traditional

N/T PROTEIN CONTROL PY

K962407 · Behring Diagnostics, Inc. · Hematology
Jul 1996
Decision
38d
Days
Class 2
Risk

About This 510(k) Submission

K962407 is an FDA 510(k) clearance for the N/T PROTEIN CONTROL PY, a Plasma, Fibrinogen Control (Class II — Special Controls, product code GIL), submitted by Behring Diagnostics, Inc. (Westwood, US). The FDA issued a Cleared decision on July 29, 1996, 38 days after receiving the submission on June 21, 1996. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7340.

Submission Details

510(k) Number K962407 FDA.gov
FDA Decision Cleared SESE
Date Received June 21, 1996
Decision Date July 29, 1996
Days to Decision 38 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GIL — Plasma, Fibrinogen Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7340

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