510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K052794Substantially Equivalent

Eti-Max 3000

Diasorin Inc., Stillwater MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K052794 is the FDA 510(k) clearance record for ETI-MAX 3000, a class I device, cleared for DiaSorin, Inc. on under FDA product code JJF (Analyzer, Chemistry, Micro, For Clinical Use). FDA records list 74 510(k) clearances for DiaSorin, Inc., from to . As of , FDA records show no recalls naming K052794.

Clearance record

Decision date
Received
(179 days to decision)
Product code
JJF Analyzer, Chemistry, Micro, For Clinical Use
Regulation
21 CFR 862.2170
Device class
Class I
Review panel
Clinical Chemistry
Applicant
DiaSorin, Inc. 1951 Northwestern Ave., Stillwater MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JJF

Trailing 12 months

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

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