Device Classification Name |
Visual, Pregnancy Hcg, Prescription Use
|
510(k) Number |
K032563 |
Device Name |
CLINITEST HCG PREGNANCY TEST |
Applicant |
BAYER HEALTHCARE, LLC |
63 NORTH ST. |
MEDFIELD,
MA
02052
|
|
Applicant Contact |
MARY GRAY |
Correspondent |
BAYER HEALTHCARE, LLC |
63 NORTH ST. |
MEDFIELD,
MA
02052
|
|
Correspondent Contact |
MARY GRAY |
Regulation Number | 862.1155
|
Classification Product Code |
|
Date Received | 08/20/2003 |
Decision Date | 12/23/2003 |
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
|
Recalls |
CDRH Recalls
|
|
|