510(k) K091960
K091960 is an FDA 510(k) premarket notification submitted by Abbott Molecular, Inc. for the device "VYSIS EGR1 FISH PROBE KIT (VYSIS LSI EGR1 SPECTRUM/ORANGE/D5S23, D5S721, SPECTRUM GREEN PROBE), MODEL 4N37-020". The FDA issued a decision of Substantially Equivalent on August 29, 2011. The device falls under product code OWK (Early Growth Response 1 (Egr) Fish Probe Kit), a Class II device regulated under 21 CFR 866.6040. Abbott Molecular, Inc. has at least 10 other 510(k) clearances on record.
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.