Device Classification Name |
lambda, rhodamine, antigen, antiserum, control
|
510(k) Number |
K023368 |
Device Name |
TRUCATH.IP |
Applicant |
AORTECH CRITICAL CARE LTD. |
PHOENIX CRESCENT |
STRATHCLYDE BUSINESS PARK |
BELLSHILL, LANARKSHIRE,
GB
ML4 3NJ
|
|
Applicant Contact |
PAUL BURNS |
Correspondent |
AORTECH CRITICAL CARE LTD. |
PHOENIX CRESCENT |
STRATHCLYDE BUSINESS PARK |
BELLSHILL, LANARKSHIRE,
GB
ML4 3NJ
|
|
Correspondent Contact |
PAUL BURNS |
Regulation Number | 866.5550
|
Classification Product Code |
|
Date Received | 10/08/2002 |
Decision Date | 10/28/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Immunology
|
510k Review Panel |
Immunology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|