Device Classification Name |
system, test, human chorionic gonadotropin
|
510(k) Number |
K072500 |
Device Name |
ONE STEP HCG URINE/SERUM TEST |
Applicant |
Guangzhou Wondfo Biotech Co., Ltd. |
8903 SPRUCE MILL DRIVE |
YARDLEY,
PA
19067
|
|
Applicant Contact |
HOWARD MANN |
Correspondent |
Guangzhou Wondfo Biotech Co., Ltd. |
8903 SPRUCE MILL DRIVE |
YARDLEY,
PA
19067
|
|
Correspondent Contact |
HOWARD MANN |
Regulation Number | 862.1155
|
Classification Product Code |
|
Date Received | 09/05/2007 |
Decision Date | 04/21/2009 |
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
|
|
|