Miris Human Milk Analyzer (HMA)— 510(k) K223085

Substantially Equivalent

Miris AB

FDA 510(k) clearance K223085 for Miris Human Milk Analyzer (HMA), Substantially Equivalent on 2023-09-29. Applicant: Miris AB. Device class: 2.

Clearance details

Applicant
Miris AB
Product code
Code QEI
Device class
Class 2
Regulation
21 CFR 862.1493
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Uppsala, SE
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