Dna Fish Probe Kit For Specimen Characterization, Human Chromosome, Hematological Disorders
The DNA FISH Probe Kit for Specimen Characterization of Human Chromosomes in Hematological Disorders is a hematology in vitro diagnostic device that detects DNA probe targets on human chromosomes in bone marrow and peripheral blood specimens to characterize chromosomal abnormalities associated with hematological malignancies and disorders. It falls under the Hematology medical specialty and is classified as a Class 2 device under regulation 864.1870, requiring 510(k) premarket notification. FISH-based cytogenetic testing is a standard tool in the diagnosis and prognostic assessment of blood cancers such as leukemia and lymphoma. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- PFG
- Device Class
- FDA class 2
- Regulation Number
- 864.1870
- Medical Specialty
- Hematology
- Review Panel
- PA
- Submission Type
- 1
Device Characteristics
Definition
DNA FISH probe kits for specimen characterization detect DNA probe targets on human chromosomes in bone marrow and peripheral blood specimens.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K131508 | VYSIS D7S486/CEP 7 FISH PROBE KIT | Sep 13, 2013 | Substantially Equivalent | Abbott Molecular, Inc. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.