Device Classification Name |
calibrator, secondary
|
510(k) Number |
K964368 |
Device Name |
ELECSYS CEA ASSAY |
Applicant |
BOEHRINGER MANNHEIM CORP. |
2400 BISSO LN. |
CONCORD,
CA
94524
|
|
Applicant Contact |
MARY KONING |
Correspondent |
BOEHRINGER MANNHEIM CORP. |
2400 BISSO LN. |
CONCORD,
CA
94524
|
|
Correspondent Contact |
MARY KONING |
Regulation Number | 862.1150
|
Classification Product Code |
|
Date Received | 11/01/1996 |
Decision Date | 06/16/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Immunology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|