510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K861881Substantially Equivalent

Rubalex (Revised Version)

Orion Corp., 20101 Turku, FI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K861881 is the FDA 510(k) clearance record for RUBALEX (REVISED VERSION), a class II device, cleared for Orion Corp. on under FDA product code LQN (Latex Agglutination Assay, Rubella). FDA records list 19 510(k) clearances for Orion Corp., from to . As of , FDA records show no recalls naming K861881.

Clearance record

Decision date
Received
(27 days to decision)
Product code
LQN Latex Agglutination Assay, Rubella
Regulation
21 CFR 866.3510
Device class
Class II
Review panel
Microbiology
Applicant
Orion Corp. P.O. Box 425, 20101 Turku, FI
Third party review
No

Clearances, product code LQN

Trailing 12 months

FDA records hold no clearances under product code LQN in the trailing twelve months.

FDA records show no clearances under product code LQN in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LQN, 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