INTERLAB ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM— 510(k) K040146

Name: FDA 510(k) clearance K040146
Creator: U.S. Food and Drug Administration
Published: 2004-05-04

Substantially Equivalent

Interlab S.R.L.

FDA 510(k) clearance K040146 for INTERLAB ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM, Substantially Equivalent on 2004-05-04. Applicant: Interlab S.R.L.. Device class: 2.

Clearance details

Applicant: Interlab S.R.L.
Product code: Code GKA
Device class: Class 2
Regulation: 21 CFR 864.7415
Advisory panel: Hematology
Date received: 2004-01-22
Decision date: 2004-05-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: East Stroudsburg, PA, US

Download summary PDF View on FDA.gov ↗

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