510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K894609Substantially Equivalent

Mardx Lyme Disease Ifa (Igm) Test System

Mardx, Inc., Scotch Plains NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K894609 is the FDA 510(k) clearance record for MARDX LYME DISEASE IFA (IGM) TEST SYSTEM, a class II device, cleared for Mardx, Inc. on under FDA product code LSR (Reagent, Borrelia Serological Reagent). FDA records list one 510(k) clearance for Mardx, Inc. As of , FDA records show no recalls naming K894609.

Clearance record

Decision date
Received
(61 days to decision)
Product code
LSR Reagent, Borrelia Serological Reagent
Regulation
21 CFR 866.3830
Device class
Class II
Review panel
Microbiology
Applicant
Mardx, Inc. 847 Jerusalem Rd., Scotch Plains NJ
Third party review
No

Clearances, product code LSR

Trailing 12 months
2 clearances under product code LSR in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LSR, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260