Cleared Traditional

MICROGEL ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM, MICROGEL ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM

K053571 · Interlab S.R.L. · Hematology

Jun 2006

Decision

190d

Days

Class 2

Risk

About This 510(k) Submission

K053571 is an FDA 510(k) clearance for the MICROGEL ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM, MICROGEL ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM, a System, Analysis, Electrophoretic Hemoglobin (Class II — Special Controls, product code JBD), submitted by Interlab S.R.L. (East Stroudsburg, US). The FDA issued a Cleared decision on June 30, 2006, 190 days after receiving the submission on December 22, 2005. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7440.

Submission Details

510(k) Number	K053571 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 22, 2005
Decision Date	June 30, 2006
Days to Decision	190 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	Statement