Product code OWK

Device name: Early Growth Response 1 (Egr) Fish Probe Kit
Medical specialty: Immunology
Device class: 2
Regulation number: 866.6040
Review panel: PA
Implant: N
Life sustaining/supporting: N
GMP exempt: N
Third party review: Y
Summary malfunction reporting: Eligible
Definition: The egr1 fish probe kit is intended to detect deletion of the lsi egr1 probe target in bone marrow specimens and may be used, in addition to cytogenetics, other biomarkers, morphology, and other clinical information, at the time of diagnosis as an aid in determining the prognosis of acute myeloid leukemia (aml) patients.
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K091960	VYSIS EGR1 FISH PROBE KIT (VYSIS LSI EGR1 SPECTRUM/ORANGE/D5S23, D5S721, SPECTRUM GREEN PROBE), MODEL 4N37-020	Abbott Molecular, Inc.	2011-08-29

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