510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K061842Substantially Equivalent

Quanta Lite Pbc Screen Igg/iga Elisa

Inova Diagnostics, Inc., San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K061842 is the FDA 510(k) clearance record for QUANTA LITE PBC SCREEN IGG/IGA ELISA, a class II device, cleared for Inova Diagnostics, Inc. on under FDA product code NRI (Autoantibodies, Nuclear Pore Glycoprotein Gp210). FDA's definition for product code NRI reads: "The device is used for the detection, in human serum or plasma, of autoantibodies to gp210 (nuclear pore glycoprotein gp210) as an aid in the diagnosis of primary biliary cirrhosis". FDA records list 138 510(k) clearances for Inova Diagnostics, Inc., from to . As of , FDA records show no recalls naming K061842.

Clearance record

Decision date
Received
(111 days to decision)
Product code
NRI Autoantibodies, Nuclear Pore Glycoprotein Gp210
Regulation
21 CFR 866.5090
Device class
Class II
Review panel
Immunology
Applicant
Inova Diagnostics, Inc. 9900 Old Grove Rd., San Diego CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NRI

Trailing 12 months

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

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