510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K941509Substantially Equivalent

Radias Ana Screen Enzyme Immunoassay

Bio-Rad, Hercules CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K941509 is the FDA 510(k) clearance record for RADIAS ANA SCREEN ENZYME IMMUNOASSAY, a class II device, cleared for Bio-Rad on under FDA product code LJM (Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls). FDA records list 319 510(k) clearances for Bio-Rad, from to . As of , FDA records show no recalls naming K941509.

Clearance record

Decision date
Received
(93 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
Bio-Rad 4000 Alfred Nobel Dr., Hercules CA
510(k) summary
Statement
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 November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LJM, 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