Device Classification Name |
radioimmunoassay, thyroid-stimulating hormone
|
510(k) Number |
K760801 |
Device Name |
TSH RIA KIT |
Applicant |
DIAGNOSTIC PRODUCTS CORP. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
DIAGNOSTIC PRODUCTS CORP. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 862.1690
|
Classification Product Code |
|
Date Received | 10/12/1976 |
Decision Date | 11/01/1976 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Immunology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|