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510(k) K091960

VYSIS EGR1 FISH PROBE KIT (VYSIS LSI EGR1 SPECTRUM/ORANGE/D5S23, D5S721, SPECTRUM GREEN PROBE), MODEL 4N37-020 by Abbott Molecular, Inc. — Product Code OWK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 2011
Date Received
July 1, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Early Growth Response 1 (Egr) Fish Probe Kit
Device Class
Class II
Regulation Number
866.6040
Review Panel
PA
Submission Type

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.

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