510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K202541Substantially Equivalent

EliA RNA Pol III

Phadia AB, Uppsala, SE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K202541 is the FDA 510(k) clearance record for EliA RNA Pol III, a class II device, cleared for Phadia AB on under FDA product code NYO (Autoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody). FDA's definition for product code NYO reads: "The anti-rna polymerase iii test is a semi-quantitative elisa for the detection of anti-rna polymerase iii antibodies in human serum. The test result is used as an aid in the diagnosis of systemic sclerosis (ssc) in conjunction with the...". FDA records list 56 510(k) clearances for Phadia AB, from to . As of , FDA records show no recalls naming K202541.

Clearance record

Decision date
Received
(376 days to decision)
Product code
NYO Autoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody
Regulation
21 CFR 866.5100
Device class
Class II
Review panel
Immunology
Applicant
Phadia AB Rapsgatan 7p, Uppsala, SE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NYO

Trailing 12 months

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

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