510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K960182Substantially Equivalent

Dsdna Immunoglobulin Eia Test System

Mardx Diagnostics, Inc., Carlsbad CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K960182 is the FDA 510(k) clearance record for DSDNA IMMUNOGLOBULIN EIA TEST SYSTEM, a class II device, cleared for Mardx Diagnostics, Inc. on under FDA product code LRM (Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control). FDA records list 8 510(k) clearances for Mardx Diagnostics, Inc., from to . As of , FDA records show no recalls naming K960182.

Clearance record

Decision date
Received
(64 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
Mardx Diagnostics, Inc. 5919 Farnsworth Ct., Carlsbad CA
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