Device Classification Name |
Radioimmunoassay, Free Thyroxine
|
510(k) Number |
K842482 |
Device Name |
AMERLEX-M FREE T-4 RADIOIMMUNOASSAY KIT |
Applicant |
AMERSHAM CORP. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
AMERSHAM CORP. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 862.1695
|
Classification Product Code |
|
Date Received | 06/25/1984 |
Decision Date | 08/10/1984 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|