510(k) DEN130010

VYSIS EGR1 FISH PROBE KIT - SC (SPECIMEN CHARACTERIZATION) by Abbott Molecular, Inc. — Product Code PDO

Clearance Details

Decision: DENG (De Novo Granted)
Decision Date: July 29, 2013
Date Received: April 9, 2013
Clearance Type: Post-NSE
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Early Growth Response Gene 1 (Egr1) Fish Probe Kit For Specimen Characterization
Device Class: Class II
Regulation Number: 864.1870
Review Panel: PA
Submission Type

The EGR1 FISH Probe Kit for specimen characterization detects the LSI EGR1 probe target on chromosome 5q in bone marrow specimens. This assay is used to characterize bone marrow specimens from patients with acute myeloid leukemia (AML) or myelodysplastic syndrome. The assay results are to be interpreted by a qualified pathologist or cytogeneticist.

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K233349 — Alinity m HSV 1 & 2 / VZV (May 3, 2024)
K222379 — Alinity m STI Assay (March 3, 2023)
K212778 — Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No. 09N (July 15, 2022)