Cleared Traditional

INTERLAB ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM

K032862 · Interlab S.R.L. · Hematology
Feb 2004
Decision
144d
Days
Class 2
Risk

About This 510(k) Submission

K032862 is an FDA 510(k) clearance for the INTERLAB ALKALINE 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 February 3, 2004, 144 days after receiving the submission on September 12, 2003. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7440.

Submission Details

510(k) Number K032862 FDA.gov
FDA Decision Cleared SESE
Date Received September 12, 2003
Decision Date February 03, 2004
Days to Decision 144 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code JBD — System, Analysis, Electrophoretic Hemoglobin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7440

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