510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K992552Substantially Equivalent

Copalis Treponemal Antigen Total Antibody Assay

Diasorin Inc., Columbia MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K992552 is the FDA 510(k) clearance record for COPALIS TREPONEMAL ANTIGEN TOTAL ANTIBODY ASSAY, a class II device, cleared for DiaSorin, Inc. on under FDA product code LIP (Enzyme Linked Immunoabsorption Assay, Treponema Pallidum). FDA records list 74 510(k) clearances for DiaSorin, Inc., from to . As of , FDA records show no recalls naming K992552.

Clearance record

Decision date
Received
(139 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
DiaSorin, Inc. 9175 Guiford Rd., Columbia MD
510(k) summary
Summary
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 November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LIP, 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