Device Classification Name |
radioimmunoassay, luteinizing hormone
|
510(k) Number |
K935319 |
Device Name |
CHEMILUMINESCENCE LH |
Applicant |
NICHOLS INSTITUTE DIAGNOSTICS |
33608 ORTEGA HIGHWAY |
SAN JUAN CAPISTRANO,
CA
92690 -6130
|
|
Applicant Contact |
DAVE D SMITH |
Correspondent |
NICHOLS INSTITUTE DIAGNOSTICS |
33608 ORTEGA HIGHWAY |
SAN JUAN CAPISTRANO,
CA
92690 -6130
|
|
Correspondent Contact |
DAVE D SMITH |
Regulation Number | 862.1485
|
Classification Product Code |
|
Date Received | 10/20/1993 |
Decision Date | 04/05/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|