Device Classification Name |
Enzyme Immunoassay, Opiates
|
510(k) Number |
K161216 |
Device Name |
Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl Urine Calibrators |
Applicant |
IMMUNALYSIS CORPORATION |
829 TOWNE CENTER DRIVE |
POMONA,
CA
91767
|
|
Applicant Contact |
Joseph Ginete |
Correspondent |
IMMUNALYSIS CORPORATION |
9975 Summers Ridge Road |
San Diego,
CA
92121
|
|
Correspondent Contact |
Michelle Bodien |
Regulation Number | 862.3650
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/29/2016 |
Decision Date | 06/14/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Toxicology
|
510k Review Panel |
Toxicology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|