Device Classification Name |
system, test, carcinoembryonic antigen
|
510(k) Number |
K980855 |
Device Name |
IMMULITE 2000 CARCINOEMBRYONIC ANTIGEN (CEA) KIT |
Applicant |
DPC CIRRUS |
B13-B18, 111 CANFIELD AVE. |
RANDOLPH,
NJ
07869
|
|
Applicant Contact |
ROBERT M DI TULLIO |
Correspondent |
DPC CIRRUS |
B13-B18, 111 CANFIELD AVE. |
RANDOLPH,
NJ
07869
|
|
Correspondent Contact |
ROBERT M DI TULLIO |
Regulation Number | 866.6010
|
Classification Product Code |
|
Date Received | 03/05/1998 |
Decision Date | 04/21/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Immunology
|
510k Review Panel |
Immunology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|