Device Classification Name |
radioimmunoassay, luteinizing hormone
|
510(k) Number |
K853142 |
Device Name |
OVUTIME OVULATION PREDICTOR TEST |
Applicant |
ADVANCED CARE PRODUCTS |
DIV. OF ORTHO PHARMACEUTICAL |
RARITAN,
NJ
08869
|
|
Applicant Contact |
JEAN GRIERE |
Correspondent |
ADVANCED CARE PRODUCTS |
DIV. OF ORTHO PHARMACEUTICAL |
RARITAN,
NJ
08869
|
|
Correspondent Contact |
JEAN GRIERE |
Regulation Number | 862.1485
|
Classification Product Code |
|
Date Received | 07/29/1985 |
Decision Date | 12/17/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|