510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K872541Substantially Equivalent

Ortho Monolert* Rapid Elisa Test for Infect. Mono.

Ortho Diagnostic Systems, Inc., Raritan NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K872541 is the FDA 510(k) clearance record for ORTHO MONOLERT* RAPID ELISA TEST FOR INFECT. MONO., a class I device, cleared for Ortho Diagnostic Systems, Inc. on under FDA product code LJN (Antibody Igm, If, Epstein-Barr Virus). FDA records list 126 510(k) clearances for Ortho Diagnostic Systems, Inc., from to . As of , FDA records show no recalls naming K872541.

Clearance record

Decision date
Received
(319 days to decision)
Product code
LJN Antibody Igm, If, Epstein-Barr Virus
Regulation
21 CFR 866.3235
Device class
Class I
Review panel
Microbiology
Applicant
Ortho Diagnostic Systems, Inc. 1001 U.S. Hwy. 202, Raritan NJ
Third party review
No

Clearances, product code LJN

Trailing 12 months
1 clearance under product code LJN in the twelve months to October 2026, October 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LJN, 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 20261