510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K113610Substantially Equivalent

Ana-Screen with Mdss

Bio-Rad Laboratories Inc., Benicia CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K113610 is the FDA 510(k) clearance record for ANA-SCREEN WITH MDSS, a class II device, cleared for Bio-Rad Laboratories on under FDA product code LKJ (Antinuclear Antibody, Antigen, Control). FDA records list 128 510(k) clearances for Bio-Rad Laboratories, from to . As of , FDA records show one recall naming K113610.

Clearance record

Decision date
Received
(216 days to decision)
Product code
LKJ Antinuclear Antibody, Antigen, Control
Regulation
21 CFR 866.5100
Device class
Class II
Review panel
Immunology
Applicant
Bio-Rad Laboratories Bioplex 2200 Division, Benicia CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LKJ

Trailing 12 months

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

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