RESOLVE HEMOGLOBIN KIT, JB-2 STAINING SYSTEM, MODELS FR-9120, FR-9400, FR-9360, FR-9367— 510(k) K050709

Clearance details

Applicant

Wallac OY

Product code

Code GKA

Device class

Class 2

Regulation

21 CFR 864.7415

Advisory panel

Hematology

Date received

2005-03-18

Decision date

2006-03-08

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Turku, FI

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• Z-2685-2017 — Multiphor II Electrophoresis System GE HealthCare Product Number: 18-1018-06 PerkinElmer Part Number: 2117-004 Product Usage: Multiphor II Electrophoresis System is a versatile modular electrophoresis system for horizontal electrophoresis, isoelectric focusing, 2-D electrophoresis and electrophoretic transfer Note: The Multiphor II Electrophoresis System (Class I) is the platform used with the hemoglobin electrophoresis gel kit ( Class II) sold by PerkinElmer as the Resolve Hemoglobin Kit (K050709: Product code JJN). The RESOLVE Systems Hemoglobin kit (K050709) is designed to separate whole blood, cord blood or dried blood spot specimen for detection of normal and variant hemoglobins by isoelectric focusing.Class II·Terminated·Perkinelmer Life Sciences, Inc.·20170515

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K050709.