510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K954380Substantially Equivalent

Quanta Lite Ssdna

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

K954380 is the FDA 510(k) clearance record for QUANTA LITE SSDNA, a class II device, cleared for Inova Diagnostics, Inc. on under FDA product code LJM (Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls). FDA records list 138 510(k) clearances for Inova Diagnostics, Inc., from to . As of , FDA records show no recalls naming K954380.

Clearance record

Decision date
Received
(163 days to decision)
Product code
LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
Regulation
21 CFR 866.5100
Device class
Class II
Review panel
Immunology
Applicant
Inova Diagnostics, Inc. 10451 Roselle St., San Diego CA
510(k) summary
Statement
Third party review
No

Clearances, product code LJM

Trailing 12 months

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

FDA records show no clearances under product code LJM in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LJM, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260