510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K060431Substantially Equivalent

Anti RNA Polymerase III Elisa Kit, Model 7805

Mbl International Corporation, Deer Field IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K060431 is the FDA 510(k) clearance record for ANTI RNA POLYMERASE III ELISA KIT, MODEL 7805, a class II device, cleared for Mbl International Corporation 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 2 510(k) clearances for Mbl International Corporation, from to . As of , FDA records show no recalls naming K060431.

Clearance record

Decision date
Received
(118 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
Mbl International Corporation P.O. Box 7007, Deer Field IL
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