PF4 ENHANCED SOLID PHASE ELISA— 510(k) K053559

Clearance details

Applicant

Genetic Testing Institute

Product code

Code LCO

Device class

Class 2

Regulation

21 CFR 864.7695

Advisory panel

Hematology

Date received

2005-12-21

Decision date

2006-01-20

Decision

Substantially Equivalent

Clearance type

Special

Location

Waukesha, WI, US

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• Z-1001-2015 — PF4 Concentrated Wash (10x), REF 403624, packaged in the following assay kits: 1. ImmucorGamma LIFECODES PF4 IgG (catalog numbers HAT13G, HAT45G) and 2. ImmucorGamma LIFECODES PF4 Enhanced (catalog numbers X-HAT13, X-HAT45) The PF4 IgG assay is an Enzyme Linked Immunosorbent Assay (ELISA). The PF4 IgG ELISA is intended to detect IgG antibodies in human serum that react with Platelet Factor 4 (PF4) when it is complexed to heparin or other polyanionic compounds. The PF4 IgG kit contains all of the reagents necessary to perform the assay.Class II·Terminated·Genetic Testing Institute,inc·20141215
• Z-1022-2013 — Gen-Probe LIFECODES PF4 Enhanced assay, Catalog No. X-HAT45 GTI PF4 Enhanced is designed as a solid phase enzyme-linked immunosorbent assay (ELISA).Class II·Terminated·Genetic Testing Institute,inc·20130204

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K053559.