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

Name: PHK: Test, Cell Mediated Immune Response, Liver And Small Bowel Transplant/Transplantation: FDA records
Creator: Arca

FDA product code PHK. Not classified. What the classification flags say about Part 820 under the QMSR.

As of Nov 2, 2026, FDA product code PHK (Test, Cell Mediated Immune Response, Liver And Small Bowel Transplant/Transplantation) is Not classified, reviewed through HDE (Humanitarian Device Exemption), with 0 linked 510(k), De Novo or BK numbers, 0 PMAs and 0 recall product records.

Classification

Product code: PHK
Device name: Test, Cell Mediated Immune Response, Liver And Small Bowel Transplant/Transplantation
Device class: Not classified
Regulation: FDA lists no classification regulation for this code
Review panel: Clinical Chemistry
Premarket route: HDE (Humanitarian Device Exemption)
CGMP-exempt flag: No
Life-sustaining flag: No
Implant flag: No
Third-party review: Not a candidate
Summary malfunction reporting: Eligible

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.

Data from openFDA as of 2 November 2026. Read the record on openFDA · FDA product code classification database

Part 820 requirements the flags point to

Part 820 rules for PHK

CGMP exemptionClassification regulation, 21 CFR parts 862 to 892: Not flaggedFDA does not flag this product code as exempt.A manufacturer of a finished device of this type falls under part 820 (21 CFR 820.1(a)). Some classification regulations exempt only part of a generic device type, so read the regulation for your device.FDA: QMSR, CGMP exemptions · 21 CFR 820.35
Design and development, ISO 13485 clause 7.321 CFR 820.10(c): Database cannot sayFDA lists this code as not classified.820.10(c) names class I, II and III devices. The database holds none of those for this code, so it cannot say whether clause 7.3 applies.21 CFR 820.10
Traceability, ISO 13485 clause 7.5.9.221 CFR 820.10(d): Not flaggedFDA does not flag this code as life-supporting or life-sustaining.820.10(d) is not indicated by this flag.21 CFR 820.10 · 21 CFR 860.3 · QMSR final rule, comment 49
Complaint and record content21 CFR 820.35: Rule names this classApplies to every finished-device manufacturer, exempt or not.820.35 adds content to complaint records, servicing records and UDI recording on top of ISO 13485 clause 4.2.5. FDA says CGMP exemption does not lift these records.21 CFR 820.35 · FDA: QMSR, CGMP exemptions

These flags describe the classification of a product code. They are not a determination for a specific device or manufacturer. How a manufacturer meets 21 CFR 820.10 depends on its own device, its intended use and the full text of the rule.

Clearances and recalls on record

510(k), De Novo and BK numbers linked: 0
PMA numbers linked: 0
Recall product records: 0
Adverse event reports: Search MAUDE for PHK

Recall records count products, and one recall event can add many. Counts show activity in a category. They do not measure its safety.

Search all 7,098 product codes, or read the guide to the Part 820 rules behind these flags.

Check your quality documents against Part 820

Arca puts your SOPs and design files in a library and compares them against the Part 820 requirements for your device in a grid, one row per document and one column per requirement, with each cell cited to its source.