GELSCAN, MODEL 1206— 510(k) K100307

Substantially Equivalent

Sebia

FDA 510(k) clearance K100307 for GELSCAN, MODEL 1206, Substantially Equivalent on 2010-08-31. Applicant: Sebia. Device class: 2.

Clearance details

Applicant: Sebia
Product code: Code CFE
Device class: Class 2
Regulation: 21 CFR 862.1445
Advisory panel: Clinical Chemistry
Date received: 2010-02-03
Decision date: 2010-08-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norcross, GA, US

Download summary PDF View on FDA.gov ↗

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