Cleared Traditional

GELSCAN, MODEL 1206

K100307 · Sebia · Chemistry
Aug 2010
Decision
209d
Days
Class 2
Risk

About This 510(k) Submission

K100307 is an FDA 510(k) clearance for the GELSCAN, MODEL 1206, a Electrophoretic, Lactate Dehydrogenase Isoenzymes (Class II — Special Controls, product code CFE), submitted by Sebia (Norcross, US). The FDA issued a Cleared decision on August 31, 2010, 209 days after receiving the submission on February 3, 2010. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1445.

Submission Details

510(k) Number K100307 FDA.gov
FDA Decision Cleared SESE
Date Received February 03, 2010
Decision Date August 31, 2010
Days to Decision 209 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code CFE — Electrophoretic, Lactate Dehydrogenase Isoenzymes
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1445

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