Device Classification Name |
Visual, Pregnancy Hcg, Prescription Use
|
510(k) Number |
K050741 |
Device Name |
IND ONE STEP HCG PREGNANCY TEST - CASSETTE FORMAT |
Applicant |
IND DIAGNOSTIC INC. |
1629 FOSTERS WAY |
DELTA, BC,
CA
V3M 6S7
|
|
Applicant Contact |
JASON PENG |
Correspondent |
IND DIAGNOSTIC INC. |
1629 FOSTERS WAY |
DELTA, BC,
CA
V3M 6S7
|
|
Correspondent Contact |
JASON PENG |
Regulation Number | 862.1155
|
Classification Product Code |
|
Date Received | 03/21/2005 |
Decision Date | 05/16/2005 |
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
|
|
|