510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K860679Substantially Equivalent for Some Indications

Immunochemical Assay of C-Reactive Protein

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

K860679 is the FDA 510(k) clearance record for IMMUNOCHEMICAL ASSAY OF C-REACTIVE PROTEIN, a class II device, cleared for Orion Corp. on under FDA product code DCN (System, Test, C-Reactive Protein). FDA records list 19 510(k) clearances for Orion Corp., from to . As of , FDA records show no recalls naming K860679.

Clearance record

Decision date
Received
(160 days to decision)
Product code
DCN System, Test, C-Reactive Protein
Regulation
21 CFR 866.5270
Device class
Class II
Review panel
Immunology
Applicant
Orion Corp. P.O. Box 425, 20101 Turku, FI
Third party review
No

Clearances, product code DCN

Trailing 12 months

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

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