Device Classification Name |
Radioassay, Vitamin B12
|
510(k) Number |
K955436 |
Device Name |
ACCESS VITAMIN B12 ASSAY (MODIFICATION) |
Applicant |
BIO-RAD LABORATORIES, INC. |
1000 LAKE HAZELTINE DR. |
CHASKA,
MN
55318 -1084
|
|
Applicant Contact |
DENNIS GRIFFIN |
Correspondent |
BIO-RAD LABORATORIES, INC. |
1000 LAKE HAZELTINE DR. |
CHASKA,
MN
55318 -1084
|
|
Correspondent Contact |
DENNIS GRIFFIN |
Regulation Number | 862.1810
|
Classification Product Code |
|
Date Received | 10/02/1995 |
Decision Date | 01/24/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|