510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K050662Substantially Equivalent

Quanta Lite Sp100 Elisa

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

K050662 is the FDA 510(k) clearance record for QUANTA LITE SP100 ELISA, a class II device, cleared for Inova Diagnostics, Inc. on under FDA product code NUM (Autoantibodies, Nuclear Body Protein, Sp100). FDA's definition for product code NUM reads: "THE DEVICE IS USED FOR THE DETECTION, IN HUMAN SERUM OR PLASMA, OF AUTOANTIBODIES TO SP100 (NUCLEAR BODY PROTEIN SP100) 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 K050662.

Clearance record

Decision date
Received
(90 days to decision)
Product code
NUM Autoantibodies, Nuclear Body Protein, Sp100
Regulation
21 CFR 866.5090
Device class
Class II
Review panel
Immunology
Applicant
Inova Diagnostics, Inc. 10180 Scripps Ranch Blvd., San Diego CA
510(k) summary
Statement
Third party review
No

Clearances, product code NUM

Trailing 12 months

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

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