510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K061165Substantially Equivalent

Elia Ccp, Model 14-5515-01; Elia Ccp Control, Model 83-1009-01

Sweden Diagnostics (Us), Inc., Portage MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K061165 is the FDA 510(k) clearance record for ELIA CCP, MODEL 14-5515-01; ELIA CCP CONTROL, MODEL 83-1009-01, a class II device, cleared for Sweden Diagnostics (Us), Inc. on under FDA product code NHX (Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)). FDA's definition for product code NHX reads: "The device is used for the detection of anti-cyclic citrullinated peptide (CCP) antibodies in human serum or plasma as an aid in the diagnosis of rheumatoid arthritis". FDA records list one 510(k) clearance for Sweden Diagnostics (Us), Inc. As of , FDA records show one recall naming K061165.

Clearance record

Decision date
Received
(99 days to decision)
Product code
NHX Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)
Regulation
21 CFR 866.5775
Device class
Class II
Review panel
Immunology
Applicant
Sweden Diagnostics (Us), Inc. 4169 Commercial Ave., Portage MI
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NHX

Trailing 12 months

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

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