510(k) DEN130010
DEN130010 is an FDA 510(k) premarket notification submitted by Abbott Molecular, Inc. for the device "VYSIS EGR1 FISH PROBE KIT - SC (SPECIMEN CHARACTERIZATION)". The FDA issued a decision of De Novo Granted on July 29, 2013. The device falls under product code PDO (Early Growth Response Gene 1 (Egr1) Fish Probe Kit For Specimen Characterization), a Class II device regulated under 21 CFR 864.1870. Abbott Molecular, Inc. has at least 10 other 510(k) clearances on record.
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.