510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K043067Substantially Equivalent

Ena Igg Beadchip Test System, Array Imaging System, Models 800-00025, Ais 400

Bioarray Solutions Limited, Warren NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K043067 is the FDA 510(k) clearance record for ENA IGG BEADCHIP TEST SYSTEM, ARRAY IMAGING SYSTEM, MODELS 800-00025, AIS 400, a class II device, cleared for Bioarray Solutions, Ltd. on under FDA product code LLL (Extractable Antinuclear Antibody, Antigen And Control). FDA records list one 510(k) clearance for Bioarray Solutions, Ltd. As of , FDA records show no recalls naming K043067.

Clearance record

Decision date
Received
(204 days to decision)
Product code
LLL Extractable Antinuclear Antibody, Antigen And Control
Regulation
21 CFR 866.5100
Device class
Class II
Review panel
Immunology
Applicant
Bioarray Solutions, Ltd. 35 Technology Dr., Warren NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LLL

Trailing 12 months
2 clearances under product code LLL in the twelve months to October 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LLL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20261
September 20260
October 20260