Device Classification Name |
Radioimmunoassay, Thyroid-Stimulating Hormone
|
510(k) Number |
K943195 |
Device Name |
COAT-A-COUNT NEONATAL TSH IRMA |
Applicant |
DIAGNOSTIC PRODUCTS CORP. |
5700 WEST 96TH ST. |
LOS ANGELES,
CA
90045 -5597
|
|
Applicant Contact |
KENNETH B ASARCH |
Correspondent |
DIAGNOSTIC PRODUCTS CORP. |
5700 WEST 96TH ST. |
LOS ANGELES,
CA
90045 -5597
|
|
Correspondent Contact |
KENNETH B ASARCH |
Regulation Number | 862.1690
|
Classification Product Code |
|
Date Received | 07/05/1994 |
Decision Date | 03/13/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|