Device Classification Name |
radioassay, vitamin b12
|
510(k) Number |
K192064 |
Device Name |
LIAISON Vitamin B12 |
Applicant |
DiaSorin Inc. |
1951 Northwestern Ave |
Stillwater,
MN
55082 -0285
|
|
Applicant Contact |
John C. Walter |
Correspondent |
DiaSorin Inc. |
1951 Northwestern Ave, P.O. Box 285 |
Stillwater,
MN
55082 -0285
|
|
Correspondent Contact |
Mari Meyer |
Regulation Number | 862.1810
|
Classification Product Code |
|
Date Received | 08/01/2019 |
Decision Date | 10/02/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|