510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K894222Substantially Equivalent

Tdxr Analyzer with Lites Tm Lithium Carousel

Abbott Medical, Irving TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K894222 is the FDA 510(k) clearance record for TDXR ANALYZER WITH LITES TM LITHIUM CAROUSEL, a class I device, cleared for Abbott Laboratories on under FDA product code JJE (Analyzer, Chemistry (Photometric, Discrete), For Clinical Use). FDA records list 1,478 510(k) clearances for Abbott Medical, from to . As of , FDA records show no recalls naming K894222.

Clearance record

Decision date
Received
(101 days to decision)
Product code
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Regulation
21 CFR 862.2160
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Abbott Laboratories 1921 Hurd Dr., Irving TX
Third party review
No

Clearances, product code JJE

Trailing 12 months

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

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