510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PFGClass II

Dna Fish Probe Kit For Specimen Characterization, Human Chromosome, Hematological Disorders

21 CFR 864.1870 / Hematology
FDA source (opens on fda.gov)

PFG is the FDA product code for Dna Fish Probe Kit For Specimen Characterization, Human Chromosome, Hematological Disorders, a class II device type, regulated under 21 CFR 864.1870. FDA's definition for this code reads: "DNA FISH probe kits for specimen characterization detect DNA probe targets on human chromosomes in bone marrow and peripheral blood specimens". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
PFG
Device name
Dna Fish Probe Kit For Specimen Characterization, Human Chromosome, Hematological Disorders
FDA definition
DNA FISH probe kits for specimen characterization detect DNA probe targets on human chromosomes in bone marrow and peripheral blood specimens.
Regulation
21 CFR 864.1870
Device class
Class II
Review panel
Hematology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
1
Ingested recalls
0

Clearances, product code PFG

By decision year
1 clearance under product code PFG with a decision year between 2013 and 2013, 2013 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PFG by decision year
YearClearances
20131

Applicants with the most clearances

Product code PFG
Applicants holding the most 510(k) clearances under product code PFG
ApplicantClearances
Abbott Molecular, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code