Device Classification Name |
Radioimmunoassay, Luteinizing Hormone
|
510(k) Number |
K013874 |
Device Name |
CLEARPLANE EASY OVULATION TEST |
Applicant |
UNIPATH LTD. |
390 PARK AVE. |
NEW YORK,
NY
10022 -4698
|
|
Applicant Contact |
STEVEN H ARMSTRONG |
Correspondent |
UNIPATH LTD. |
390 PARK AVE. |
NEW YORK,
NY
10022 -4698
|
|
Correspondent Contact |
STEVEN H ARMSTRONG |
Regulation Number | 862.1485
|
Classification Product Code |
|
Date Received | 11/21/2001 |
Decision Date | 02/19/2002 |
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
|
|
|