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510(k) K131508

VYSIS D7S486/CEP 7 FISH PROBE KIT by Abbott Molecular, Inc. — Product Code PFG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 13, 2013
Date Received
May 24, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dna Fish Probe Kit For Specimen Characterization, Human Chromosome, Hematological Disorders
Device Class
Class II
Regulation Number
864.1870
Review Panel
PA
Submission Type

DNA FISH probe kits for specimen characterization detect DNA probe targets on human chromosomes in bone marrow and peripheral blood specimens.

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