Device Classification Name |
Enzyme Immunoassay, Methadone
|
510(k) Number |
K151395 |
Device Name |
Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calibrators, Immunalysis EDDP Urine Control Sets |
Applicant |
Immunalysis Corporation |
829 Towne Center Drive |
Pomona,
CA
91767
|
|
Applicant Contact |
Joseph Ginete |
Correspondent |
Immunalysis Corporation |
829 Towne Center Drive |
Pomona,
CA
91767
|
|
Correspondent Contact |
Joseph Ginete |
Regulation Number | 862.3620
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 05/26/2015 |
Decision Date | 07/24/2015 |
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
|
Recalls |
CDRH Recalls
|
|
|