510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K952490Substantially Equivalent

Imagetiter Instrument, Ana Test Kit & Calibrator Serum

Roche Image Analysis Systems, Elon College NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K952490 is the FDA 510(k) clearance record for IMAGETITER INSTRUMENT, ANA TEST KIT & CALIBRATOR SERUM, a class II device, cleared for Roche Image Analysis Systems on under FDA product code LJM (Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls). FDA records list one 510(k) clearance for Roche Image Analysis Systems. As of , FDA records show no recalls naming K952490.

Clearance record

Decision date
Received
(199 days to decision)
Product code
LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
Regulation
21 CFR 866.5100
Device class
Class II
Review panel
Immunology
Applicant
Roche Image Analysis Systems 112 Orange Dr., Elon College NC
510(k) summary
Summary
Third party review
No

Clearances, product code LJM

Trailing 12 months

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

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