Cleared Traditional

N/T PROTEIN CONTROL PY

K951012 · Behring Diagnostics, Inc. · Hematology
Apr 1995
Decision
42d
Days
Class 2
Risk

About This 510(k) Submission

K951012 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 April 17, 1995, 42 days after receiving the submission on March 6, 1995. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7340.

Submission Details

510(k) Number K951012 FDA.gov
FDA Decision Cleared SESE
Date Received March 06, 1995
Decision Date April 17, 1995
Days to Decision 42 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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