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

Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase

Unknown
FDA source (opens on fda.gov)

PKW is the FDA product code for Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase, a class III device type. FDA's definition for this code reads: "The anaplastic lymphoma kinase (ALK) antibody is a qualitative immunohistochemical antibody intended to identify ALK protein expression in human clinical tissue specimens. The ALK antibody is indicated as an aid in identifying patients eligible for treatment with specific FDA approved therapeutic drugs". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
PKW
Device name
Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase
FDA definition
The anaplastic lymphoma kinase (ALK) antibody is a qualitative immunohistochemical antibody intended to identify ALK protein expression in human clinical tissue specimens. The ALK antibody is indicated as an aid in identifying patients eligible for treatment with specific FDA approved therapeutic drugs.
Device class
Class III
Review panel
Unknown
Submission type
PMA
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