Device Classification Name |
radioimmunoassay, thyroid-stimulating hormone
|
510(k) Number |
K860054 |
Device Name |
TSH-IRMA COAT-A-COUNT KIT |
Applicant |
DIAGNOSTIC PRODUCTS CORP. |
5700 WEST 96TH ST. |
LOS ANGELES,
CA
90045 -5597
|
|
Applicant Contact |
ZIERING, PH.D. |
Correspondent |
DIAGNOSTIC PRODUCTS CORP. |
5700 WEST 96TH ST. |
LOS ANGELES,
CA
90045 -5597
|
|
Correspondent Contact |
ZIERING, PH.D. |
Regulation Number | 862.1690
|
Classification Product Code |
|
Date Received | 01/06/1986 |
Decision Date | 03/17/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|