510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K931543Substantially Equivalent

Encore Ena Combined Eia

Trinity Biotech USA, Blairstown NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K931543 is the FDA 510(k) clearance record for ENCORE ENA COMBINED EIA, a class II device, cleared for Clark Laboratories, Inc. on under FDA product code LLL (Extractable Antinuclear Antibody, Antigen And Control). FDA records list 25 510(k) clearances for Trinity Biotech USA, from to . As of , FDA records show no recalls naming K931543.

Clearance record

Decision date
Received
(163 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
Clark Laboratories, Inc. 53 Cedar Lake Rd., Blairstown NJ
510(k) summary
Summary
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