Device Classification Name |
Radioimmunoassay, Luteinizing Hormone
|
510(k) Number |
K862180 |
Device Name |
MODIFIED COTROPIN RADIOIMMUNOASSAY KIT |
Applicant |
CLINETICS CORP. |
2991 DOW AVE. |
TUSTIN,
CA
92680
|
|
Applicant Contact |
EILEEN TEMPLETON |
Correspondent |
CLINETICS CORP. |
2991 DOW AVE. |
TUSTIN,
CA
92680
|
|
Correspondent Contact |
EILEEN TEMPLETON |
Regulation Number | 862.1485
|
Classification Product Code |
|
Date Received | 06/09/1986 |
Decision Date | 07/07/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|