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

Fluorescence In Situ Hybridization, Chromosome 17p Deletion (Tp53)

21 CFR 864.1890 / Pathology
FDA source (opens on fda.gov)

PNK is the FDA product code for Fluorescence In Situ Hybridization, Chromosome 17p Deletion (Tp53), a class III device type. FDA's definition for this code reads: "A chromosome 17p deletion (TP53) fluorescence in situ hybridization (FISH) kit is a test to detect deletion of the TP53 gene in peripheral blood specimens from patients with B-cell chronic lymphocytic leukemia (CLL)". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
PNK
Device name
Fluorescence In Situ Hybridization, Chromosome 17p Deletion (Tp53)
FDA definition
A chromosome 17p deletion (TP53) fluorescence in situ hybridization (FISH) kit is a test to detect deletion of the TP53 gene in peripheral blood specimens from patients with B-cell chronic lymphocytic leukemia (CLL).
Regulation
21 CFR 864.1890
Device class
Class II
Review panel
Pathology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code