510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K935047Substantially Equivalent

Auto Delfia

Wallac Oy, Finland, FI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K935047 is the FDA 510(k) clearance record for AUTO DELFIA, a class I device, cleared for Wallac OY on under FDA product code KHO (Fluorometer, For Clinical Use). FDA records list 24 510(k) clearances for Wallac OY, from to . As of , FDA records show 3 recalls naming K935047.

Clearance record

Decision date
Received
(214 days to decision)
Product code
KHO Fluorometer, For Clinical Use
Regulation
21 CFR 862.2560
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Wallac OY P.O. Box 10, Finland, FI
510(k) summary
Summary
Third party review
No

Clearances, product code KHO

Trailing 12 months

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

FDA records show no clearances under product code KHO in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KHO, 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