Device Classification Name |
Helicobacter Pylori
|
510(k) Number |
K161139 |
Device Name |
LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set |
Applicant |
DIASORIN, INC. |
1951 NORTHWESTERN AVE. |
STILLWATER,
MN
55082 -0285
|
|
Applicant Contact |
JOHN WALTER |
Correspondent |
DIASORIN, INC. |
1951 NORTHWESTERN AVE. |
STILLWATER,
MN
55082 -0285
|
|
Correspondent Contact |
KELLY R. SAUER |
Regulation Number | 866.3110
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 04/22/2016 |
Decision Date | 07/22/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|