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

Test, Volatile Organic Compounds Breath Analysis

Unknown
FDA source (opens on fda.gov)

PAR is the FDA product code for Test, Volatile Organic Compounds Breath Analysis. FDA's definition for this code reads: "Aid in the diagnosis of grade 3 heart transplant rejection in patients who have received heart transplants within the preceding year. Intended to be used as an adjunct to, and not as a substitute for, endomyocardial biopsy. The use of the device is limited to patients who have had endomyocardial biopsy within the...". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
PAR
Device name
Test, Volatile Organic Compounds Breath Analysis
FDA definition
Aid in the diagnosis of grade 3 heart transplant rejection in patients who have received heart transplants within the preceding year. Intended to be used as an adjunct to, and not as a substitute for, endomyocardial biopsy. The use of the device is limited to patients who have had endomyocardial biopsy within the previous month.
Device class
Humanitarian device exemption
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

No registered establishment in MDM’s records lists product code PAR.