Device Classification Name |
enzyme immunoassay, opiates
|
510(k) Number |
K150606 |
Device Name |
Emit II Plus Buprenorphine Assay, Emit II Plus Specialty Drug Calibrator/Control Level 1, Level 2 Level 3, Level 4, Emit II Plus Specialty Drug Control Negative, Emit II Plus Specialty Drug Control Positive |
Applicant |
SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
P.O. BOX 6101, M/S 514 |
NEWARK,
DE
19714 -6101
|
|
Applicant Contact |
FRANCES A. DILLON |
Correspondent |
SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
P.O. BOX 6101, M/S 514 |
NEWARK,
DE
19714 -6101
|
|
Correspondent Contact |
FRANCES A. DILLON |
Regulation Number | 862.3650
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 03/10/2015 |
Decision Date | 10/23/2015 |
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
|
|
|