Cleared Traditional

INTERLAB ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM

K040146 · Interlab S.R.L. · Hematology
May 2004
Decision
103d
Days
Class 2
Risk

About This 510(k) Submission

K040146 is an FDA 510(k) clearance for the INTERLAB ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM, a Abnormal Hemoglobin Quantitation (Class II — Special Controls, product code GKA), submitted by Interlab S.R.L. (East Stroudsburg, US). The FDA issued a Cleared decision on May 4, 2004, 103 days after receiving the submission on January 22, 2004. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7415.

Submission Details

510(k) Number K040146 FDA.gov
FDA Decision Cleared SESE
Date Received January 22, 2004
Decision Date May 04, 2004
Days to Decision 103 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GKA — Abnormal Hemoglobin Quantitation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7415

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