Device Classification Name |
Radioimmunoassay, Thyroid-Stimulating Hormone
|
510(k) Number |
K081074 |
Device Name |
DIMENSION TSHL FLEX REAGENT CARTRIDGE AND TSH SAMPLE DILUENT WITH MODELS RF 612 AND KD691 |
Applicant |
Siemens Healthcare Diagnostics Inc. |
PO BOX 6101 |
MAILBOX 514 |
NEWARK,
DE
19714 -6101
|
|
Applicant Contact |
YUK-TING LEWIS |
Correspondent |
Siemens Healthcare Diagnostics Inc. |
PO BOX 6101 |
MAILBOX 514 |
NEWARK,
DE
19714 -6101
|
|
Correspondent Contact |
YUK-TING LEWIS |
Regulation Number | 862.1690
|
Classification Product Code |
|
Date Received | 04/16/2008 |
Decision Date | 05/23/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|