Device Classification Name |
Reagent, Occult Blood
|
510(k) Number |
K110309 |
Device Name |
FOB ONE STEP RAPID TEST |
Applicant |
ORIENT GENE BIOTECH |
150 CHERRY LANE RD |
EAST STROUDSBURG,
PA
18301
|
|
Applicant Contact |
Gary Lehnus |
Correspondent |
ORIENT GENE BIOTECH |
150 CHERRY LANE RD |
EAST STROUDSBURG,
PA
18301
|
|
Correspondent Contact |
Gary Lehnus |
Regulation Number | 864.6550
|
Classification Product Code |
|
Date Received | 02/02/2011 |
Decision Date | 09/14/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|