INTERLAB ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM— 510(k) K032862

Name: FDA 510(k) clearance K032862
Creator: U.S. Food and Drug Administration
Published: 2004-02-03

Substantially Equivalent

Interlab S.R.L.

FDA 510(k) clearance K032862 for INTERLAB ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM, Substantially Equivalent on 2004-02-03. Applicant: Interlab S.R.L.. Device class: 2.

Clearance details

Applicant: Interlab S.R.L.
Product code: Code JBD
Device class: Class 2
Regulation: 21 CFR 864.7440
Advisory panel: Hematology
Date received: 2003-09-12
Decision date: 2004-02-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: East Stroudsburg, PA, US

Download summary PDF View on FDA.gov ↗

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K992199 — ACID HEMOGLOBIN KIT1999-09-21
K991362 — HYDRAGEL HEMOGLOBIN(E), MINI HEMOGLOBIN(E), 7 HEMOGLOBIN(E), 15 HEMOGLOBIN(E), ACID(E) HEMOGLOBIN(E), MINI ACID(E) HEMO)1999-06-21
K982426 — SPIFE ALKALINE HEMOGLOBIN1998-12-17
K931503 — REP HEMOGLOBIN IEF KITS (CAT. NO. 3250)1993-08-16

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K040146 — INTERLAB ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM2004-05-04
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