DeviceClearance

Product code PFG— Hematology

VYSIS D7S486/CEP 7 FISH PROBE KIT

Classification name
Dna Fish Probe Kit For Specimen Characterization, Human Chromosome, Hematological Disorders
Device class
Class 2
Regulation
21 CFR 864.1870
Advisory panel
Hematology
Total cleared
1
First cleared
Most recent

FDA classification definition

“DNA FISH probe kits for specimen characterization detect DNA probe targets on human chromosomes in bone marrow and peripheral blood specimens.”

— U.S. Food and Drug Administration, device classification record for product code PFG under 21 CFR 864.1870, via openFDA

Market context for product code PFG

FDA has cleared 1 device under product code PFG, all in 2013, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code PFG

Recent clearances under product code PFG

Data sourced from openFDA. This site is unofficial and independent of the FDA.