Device Classification Name |
Radioimmunoassay, Luteinizing Hormone
|
510(k) Number |
K013582 |
Device Name |
MAYBE?MOM MINI OVULATION MICROSCOPE |
Applicant |
MAYBE?MOM |
22 CHURCH ST. |
SUITE 103-244 |
RAMSEY,
NJ
07446
|
|
Applicant Contact |
TONI MILLERVA |
Correspondent |
MAYBE?MOM |
22 CHURCH ST. |
SUITE 103-244 |
RAMSEY,
NJ
07446
|
|
Correspondent Contact |
TONI MILLERVA |
Regulation Number | 862.1485
|
Classification Product Code |
|
Date Received | 10/30/2001 |
Decision Date | 01/16/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|