Cleared Traditional

SIGMA DIAGNOSTICS ACCUCLOT LA CONTROL

K020109 · Sigma Diagnostics, Inc. · Hematology
Feb 2002
Decision
26d
Days
Class 2
Risk

About This 510(k) Submission

K020109 is an FDA 510(k) clearance for the SIGMA DIAGNOSTICS ACCUCLOT LA CONTROL, a Control, Plasma, Abnormal (Class II — Special Controls, product code GGC), submitted by Sigma Diagnostics, Inc. (St. Louis, US). The FDA issued a Cleared decision on February 6, 2002, 26 days after receiving the submission on January 11, 2002. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5425.

Submission Details

510(k) Number K020109 FDA.gov
FDA Decision Cleared SESE
Date Received January 11, 2002
Decision Date February 06, 2002
Days to Decision 26 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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