510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K881369Substantially Equivalent

Advance Diagnostics Disposable Eyecup

Advantage Diagnostics Corp., Tucson AZ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K881369 is the FDA 510(k) clearance record for ADVANCE DIAGNOSTICS DISPOSABLE EYECUP, cleared for Advantage Diagnostics Corp. on under FDA product code LXQ (Cup, Eye). FDA records list 10 510(k) clearances for Advantage Diagnostics Corp., from to . As of , FDA records show no recalls naming K881369.

Clearance record

Decision date
Received
(42 days to decision)
Product code
LXQ Cup, Eye
Device class
Unclassified
Review panel
Unknown
Applicant
Advantage Diagnostics Corp. P.O. Box 12428, Tucson AZ
Third party review
No

Clearances, product code LXQ

Trailing 12 months

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

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