510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K850329Substantially Equivalent

Cordia S4 -Treponema Pallidum

Cordis US Corp., Miami FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K850329 is the FDA 510(k) clearance record for CORDIA S4 -TREPONEMA PALLIDUM, a class II device, cleared for Cordis Corp. on under FDA product code LIP (Enzyme Linked Immunoabsorption Assay, Treponema Pallidum). FDA records list 332 510(k) clearances for Cordis US Corp., from to . As of , FDA records show no recalls naming K850329.

Clearance record

Decision date
Received
(155 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
Cordis Corp. P.O. Box 025700, Miami FL
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