Device Classification Name |
radioimmunoassay, free thyroxine
|
510(k) Number |
K182423 |
Device Name |
MAGLUMI 2000 FT4 |
Applicant |
Shenzhen New Industries Biomedical Engineering Co., Ltd |
No.16, Jinhui Road, Pingshan New District |
Shenzhen,
CN
518122
|
|
Applicant Contact |
Jie Rao |
Correspondent |
LSI International Inc |
504E Diamond Ave., Suite F |
Gaithersburg,
MD
20877
|
|
Correspondent Contact |
Joe Shia |
Regulation Number | 862.1695
|
Classification Product Code |
|
Date Received | 09/06/2018 |
Decision Date | 10/04/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|