Device Classification Name |
visual, pregnancy hcg, prescription use
|
510(k) Number |
K894012 |
Device Name |
MINICLINIC PREGNANCY TEST |
Applicant |
VANGUARD BIOMEDICAL CORP. |
7822 CONVOY COURT |
SAN DIEGO,
CA
92111
|
|
Applicant Contact |
CHIU, PH.D. |
Correspondent |
VANGUARD BIOMEDICAL CORP. |
7822 CONVOY COURT |
SAN DIEGO,
CA
92111
|
|
Correspondent Contact |
CHIU, PH.D. |
Regulation Number | 862.1155
|
Classification Product Code |
|
Date Received | 06/06/1989 |
Decision Date | 07/25/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|