510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K992665Substantially Equivalent

Macra Lp(a) Enzyme Immunoassay Kit

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

K992665 is the FDA 510(k) clearance record for MACRA LP(A) ENZYME IMMUNOASSAY KIT, a class II device, cleared for Trinity Biotech USA on under FDA product code DFC (Lipoprotein, Low-Density, Antigen, Antiserum, Control). FDA records list 25 510(k) clearances for Trinity Biotech USA, from to . As of , FDA records show no recalls naming K992665.

Clearance record

Decision date
Received
(109 days to decision)
Product code
DFC Lipoprotein, Low-Density, Antigen, Antiserum, Control
Regulation
21 CFR 866.5600
Device class
Class II
Review panel
Immunology
Applicant
Trinity Biotech USA P.O. Box 1059, Jamestown NY
510(k) summary
Statement
Third party review
No

Clearances, product code DFC

Trailing 12 months
1 clearance under product code DFC 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 DFC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260