Device Classification Name |
Paper, Obstetric Ph
|
510(k) Number |
K032161 |
Device Name |
PHEM-ALERT |
Applicant |
FEMTEK,LLC. |
11605 HITCHING POST LN. |
ROCKVILLE,
MD
20852
|
|
Applicant Contact |
JOEL S FADEN |
Correspondent |
FEMTEK,LLC. |
11605 HITCHING POST LN. |
ROCKVILLE,
MD
20852
|
|
Correspondent Contact |
JOEL S FADEN |
Regulation Number | 862.1550
|
Classification Product Code |
|
Date Received | 07/15/2003 |
Decision Date | 09/30/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|