510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K910487Substantially Equivalent

Visuwell Syphilis Antigen

Adi Diagnostics, Inc., Rexdale, Ontario, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K910487 is the FDA 510(k) clearance record for VISUWELL SYPHILIS ANTIGEN, a class II device, cleared for Adi Diagnostics, Inc. on under FDA product code LIP (Enzyme Linked Immunoabsorption Assay, Treponema Pallidum). FDA records list 4 510(k) clearances for Adi Diagnostics, Inc., from to . As of , FDA records show no recalls naming K910487.

Clearance record

Decision date
Received
(138 days to decision)
Product code
LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
Regulation
21 CFR 866.3830
Device class
Class II
Review panel
Microbiology
Applicant
Adi Diagnostics, Inc. 30 Meridian Rd., Rexdale, Ontario, CA
Third party review
No

Clearances, product code LIP

Trailing 12 months

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

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