Cleared Traditional

SIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A5217

K003329 · Sigma Diagnostics, Inc. · Hematology
Mar 2001
Decision
128d
Days
Class 2
Risk

About This 510(k) Submission

K003329 is an FDA 510(k) clearance for the SIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A5217, 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 March 1, 2001, 128 days after receiving the submission on October 24, 2000. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5425.

Submission Details

510(k) Number K003329 FDA.gov
FDA Decision Cleared SESE
Date Received October 24, 2000
Decision Date March 01, 2001
Days to Decision 128 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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