Device Classification Name |
radioimmunoassay, luteinizing hormone
|
510(k) Number |
K981271 |
Device Name |
CLEARPLAN EASY OVULATION TEST |
Applicant |
UNIPATH LTD. |
PRIORY BUSINESS PARK |
BEDFORD,
GB
MK44 3UP
|
|
Applicant Contact |
Louise Roberts |
Correspondent |
UNIPATH LTD. |
PRIORY BUSINESS PARK |
BEDFORD,
GB
MK44 3UP
|
|
Correspondent Contact |
Louise Roberts |
Regulation Number | 862.1485
|
Classification Product Code |
|
Date Received | 04/07/1998 |
Decision Date | 06/25/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|