Device Classification Name |
radioimmunoassay, luteinizing hormone
|
510(k) Number |
K893605 |
Device Name |
SRI LUTEINIZING HORMONE IMMUNOENZYMETRIC ASSAY |
Applicant |
SERONO-BAKER DIAGNOSTICS, INC. |
100 CASCADE DR. |
ALLENTOWN,
PA
18103 -9562
|
|
Applicant Contact |
TOMALESKY |
Correspondent |
SERONO-BAKER DIAGNOSTICS, INC. |
100 CASCADE DR. |
ALLENTOWN,
PA
18103 -9562
|
|
Correspondent Contact |
TOMALESKY |
Regulation Number | 862.1485
|
Classification Product Code |
|
Date Received | 05/10/1989 |
Decision Date | 06/20/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|