510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K923537Substantially Equivalent

Encore Ds-DNA

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

K923537 is the FDA 510(k) clearance record for ENCORE DS-DNA, a class II device, cleared for Clark Laboratories, Inc. on under FDA product code LRM (Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control). FDA records list 25 510(k) clearances for Trinity Biotech USA, from to . As of , FDA records show no recalls naming K923537.

Clearance record

Decision date
Received
(160 days to decision)
Product code
LRM Anti-Dna Antibody (Enzyme-Labeled), Antigen, 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 LRM

Trailing 12 months

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

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