Device Classification Name |
breast milk macronutrients test system
|
510(k) Number |
K223085 |
Device Name |
Miris Human Milk Analyzer (HMA) |
Applicant |
Miris AB |
Danmarksgatan 26 |
Uppsala,
SE
75323
|
|
Applicant Contact |
Elin Hallen |
Correspondent |
Hogan Lovell US LLP |
555 13th Street NW |
WASHINGTON,
DC
20004
|
|
Correspondent Contact |
John J Smith |
Regulation Number | 862.1493
|
Classification Product Code |
|
Date Received | 09/30/2022 |
Decision Date | 09/29/2023 |
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
|