Cleared Traditional

LYPHOCHEK HEMOSTASIS, MODELS 798, 799

K020878 · Bio-Rad · Hematology
Apr 2002
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K020878 is an FDA 510(k) clearance for the LYPHOCHEK HEMOSTASIS, MODELS 798, 799, a Control, Plasma, Abnormal (Class II — Special Controls, product code GGC), submitted by Bio-Rad (Ivrvine, US). The FDA issued a Cleared decision on April 15, 2002, 28 days after receiving the submission on March 18, 2002. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5425.

Submission Details

510(k) Number K020878 FDA.gov
FDA Decision Cleared SESE
Date Received March 18, 2002
Decision Date April 15, 2002
Days to Decision 28 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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