Device Classification Name |
radioimmunoassay, luteinizing hormone
|
510(k) Number |
K884498 |
Device Name |
COTUBE LH IRMA ASSAY |
Applicant |
BIO-RAD |
4000 ALFRED NOBEL DR. |
HERCULES,
CA
94547 -1803
|
|
Applicant Contact |
FRANK MATARRESE |
Correspondent |
BIO-RAD |
4000 ALFRED NOBEL DR. |
HERCULES,
CA
94547 -1803
|
|
Correspondent Contact |
FRANK MATARRESE |
Regulation Number | 862.1485
|
Classification Product Code |
|
Date Received | 10/26/1988 |
Decision Date | 12/22/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|