Device Classification Name |
Visual, Pregnancy Hcg, Prescription Use
|
510(k) Number |
K963132 |
Device Name |
MINI STRIP/SERUM HCG |
Applicant |
INTERNATIONAL NEWTECH DEVELOPMENT, INC. |
150-13500 MAYCREST WAY |
RICHMOND, B.C.,
CA
V6V 2N8
|
|
Applicant Contact |
JESSE ZHU |
Correspondent |
INTERNATIONAL NEWTECH DEVELOPMENT, INC. |
150-13500 MAYCREST WAY |
RICHMOND, B.C.,
CA
V6V 2N8
|
|
Correspondent Contact |
JESSE ZHU |
Regulation Number | 862.1155
|
Classification Product Code |
|
Date Received | 08/12/1996 |
Decision Date | 11/18/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|