510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K884617Substantially Equivalent

Ortho Result Plus/rubella Rapid Color. Immunoassay

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

K884617 is the FDA 510(k) clearance record for ORTHO RESULT PLUS/RUBELLA RAPID COLOR. IMMUNOASSAY, a class II device, cleared for Ortho Diagnostic Systems, Inc. on under FDA product code LFX (Enzyme Linked Immunoabsorbent Assay, Rubella). FDA records list 126 510(k) clearances for Ortho Diagnostic Systems, Inc., from to . As of , FDA records show no recalls naming K884617.

Clearance record

Decision date
Received
(90 days to decision)
Product code
LFX Enzyme Linked Immunoabsorbent Assay, Rubella
Regulation
21 CFR 866.3510
Device class
Class II
Review panel
Microbiology
Applicant
Ortho Diagnostic Systems, Inc. 1001 U.S. Hwy. 202, Raritan NJ
Third party review
No

Clearances, product code LFX

Trailing 12 months
1 clearance under product code LFX 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 LFX, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260