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

Test, Cell Mediated Immune Response, Liver And Small Bowel Transplant/Transplantation

Unknown
FDA source (opens on fda.gov)

PHK is the FDA product code for Test, Cell Mediated Immune Response, Liver And Small Bowel Transplant/Transplantation. FDA's definition for this code reads: "The test is a qualitative prognostic test intended to be used in patients less than 21 years old with liver or small bowel transplantation. The test is an aid in the evaluation of the risk of acute cellular rejection (ACR) and must be used in conjunction with biopsy, standard clinical assessment and other laboratory...". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
PHK
Device name
Test, Cell Mediated Immune Response, Liver And Small Bowel Transplant/Transplantation
FDA definition
The test is a qualitative prognostic test intended to be used in patients less than 21 years old with liver or small bowel transplantation. The test is an aid in the evaluation of the risk of acute cellular rejection (ACR) and must be used in conjunction with biopsy, standard clinical assessment and other laboratory information.
Device class
Not classified
Review panel
Unknown
Submission type
FDA code 6
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