Device Classification Name |
radioassay, vitamin b12
|
510(k) Number |
K973674 |
Device Name |
ELECSYS FOLATE |
Applicant |
BOEHRINGER MANNHEIM CORP. |
4300 HACIENDA DR. |
PLEASANTON,
CA
94588 -2722
|
|
Applicant Contact |
Patricia Klimley |
Correspondent |
BOEHRINGER MANNHEIM CORP. |
4300 HACIENDA DR. |
PLEASANTON,
CA
94588 -2722
|
|
Correspondent Contact |
Patricia Klimley |
Regulation Number | 862.1810
|
Classification Product Code |
|
Date Received | 09/26/1997 |
Decision Date | 11/12/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|