Cleared Traditional

CONTROL PLASMA P

K023312 · Dade Behring, Inc. · Hematology
Nov 2002
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K023312 is an FDA 510(k) clearance for the CONTROL PLASMA P, a Control, Plasma, Abnormal (Class II — Special Controls, product code GGC), submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on November 1, 2002, 29 days after receiving the submission on October 3, 2002. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5425.

Submission Details

510(k) Number K023312 FDA.gov
FDA Decision Cleared SESE
Date Received October 03, 2002
Decision Date November 01, 2002
Days to Decision 29 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GGC — Control, Plasma, Abnormal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5425

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