PFG — Dna Fish Probe Kit For Specimen Characterization, Human Chromosome, Hematological Disorders Class II
FDA product code PFG covers "Dna Fish Probe Kit For Specimen Characterization, Human Chromosome, Hematological Disorders", a Class II medical device regulated under 21 CFR 864.1870. Submissions are reviewed by the Hematology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- PFG
- Device Class
- Class II
- Regulation Number
- 864.1870
- Submission Type
- Review Panel
- PA
- Medical Specialty
- Hematology
- Implant
- No
Definition
DNA FISH probe kits for specimen characterization detect DNA probe targets on human chromosomes in bone marrow and peripheral blood specimens.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K131508 | abbott molecular | VYSIS D7S486/CEP 7 FISH PROBE KIT | September 13, 2013 |