Device Classification Name |
radioimmunoassay, luteinizing hormone
|
510(k) Number |
K910717 |
Device Name |
PANTEX IRMA LH 1251 KIT |
Applicant |
PANTEX, DIV. BIO-ANALYSIS, INC. |
1737 21ST ST. |
SANTA MONICA,
CA
90404
|
|
Applicant Contact |
Y CHIAMORI |
Correspondent |
PANTEX, DIV. BIO-ANALYSIS, INC. |
1737 21ST ST. |
SANTA MONICA,
CA
90404
|
|
Correspondent Contact |
Y CHIAMORI |
Regulation Number | 862.1485
|
Classification Product Code |
|
Date Received | 02/20/1991 |
Decision Date | 03/19/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|