510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN180007Unknown

Miris Human Milk Analyzer

Miris AB, Uppsala, SE / Direct, Unknown
FDA source (opens on fda.gov)

DEN180007 is the FDA 510(k) clearance record for Miris Human Milk Analyzer, a class II device, cleared for Miris AB on under FDA product code QEI (Breast Milk Macronutrients Test System). FDA's definition for product code QEI reads: "A breast milk macronutrient test system is a device intended to quantitatively measure fat, protein, and total carbohydrate content in human breast milk. These measurements, in conjunction with other clinical assessments, may be used to...". FDA records list 2 510(k) clearances for Miris AB, from to . As of , FDA records show no recalls naming DEN180007.

Clearance record

Decision date
Received
(312 days to decision)
Product code
QEI Breast Milk Macronutrients Test System
Regulation
21 CFR 862.1493
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Miris AB Kungsgatan 115, Uppsala, SE
Third party review
No

Clearances, product code QEI

Trailing 12 months

FDA records hold no clearances under product code QEI in the trailing twelve months.

FDA records show no clearances under product code QEI in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QEI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260