Device Classification Name |
saline, vascular access flush
|
510(k) Number |
K121231 |
Device Name |
IND DRUG HOME MULTI-PANEL TEST (2-5) IND MORPHINE HOME TEST |
Applicant |
IND NDIAGNOSTIC INC. |
1629 FOSTERS WAY |
DELTA, BRITISH COLUMBIA,
CA
V3M 6S7
|
|
Applicant Contact |
KAI LOU |
Correspondent |
IND NDIAGNOSTIC INC. |
1629 FOSTERS WAY |
DELTA, BRITISH COLUMBIA,
CA
V3M 6S7
|
|
Correspondent Contact |
KAI LOU |
Regulation Number | 880.5200
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 04/24/2012 |
Decision Date | 07/30/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
Toxicology
|
Statement |
Statement
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|