Device Classification Name |
Radioimmunoassay, Total Thyroxine
|
510(k) Number |
K871008 |
Device Name |
MICROMEDIC NEONATAL T4 KIT |
Applicant |
MICROMEDIC SYSTEMS |
102 WITMER RD. |
HORSHAM,
PA
19044
|
|
Applicant Contact |
DEBORAH L LINDEMUTH |
Correspondent |
MICROMEDIC SYSTEMS |
102 WITMER RD. |
HORSHAM,
PA
19044
|
|
Correspondent Contact |
DEBORAH L LINDEMUTH |
Regulation Number | 862.1700
|
Classification Product Code |
|
Date Received | 03/13/1987 |
Decision Date | 05/26/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|