Device Classification Name |
system, test, vitamin d
|
510(k) Number |
K032844 |
Device Name |
LIAISON 25 OH VITAMIN D |
Applicant |
DIASORIN, INC. |
1951 NORTHWESTERN AVE. |
P.O. BOX 285 |
STILLWATER,
MN
55082
|
|
Applicant Contact |
DAVID IKEDA |
Correspondent |
DIASORIN, INC. |
1951 NORTHWESTERN AVE. |
P.O. BOX 285 |
STILLWATER,
MN
55082
|
|
Correspondent Contact |
DAVID IKEDA |
Regulation Number | 862.1825
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/11/2003 |
Decision Date | 02/12/2004 |
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
|
Recalls |
CDRH Recalls
|
|
|