510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K983715Substantially Equivalent

The Immuno 1 Ca 125 II Assay for the Bayer Immuno 1 System (in Vitro Diagnostic System)

Bayer Corp., Tarrytown NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K983715 is the FDA 510(k) clearance record for THE IMMUNO 1 CA 125 II ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM), a class II device, cleared for Bayer Corp. on under FDA product code LTK (Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)). FDA records list 63 510(k) clearances for Bayer Corp., from to . As of , FDA records show no recalls naming K983715.

Clearance record

Decision date
Received
(205 days to decision)
Product code
LTK Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
Regulation
21 CFR 866.6010
Device class
Class II
Review panel
Immunology
Applicant
Bayer Corp. 511 Benedict Ave., Tarrytown NY
510(k) summary
Summary
Third party review
No

Clearances, product code LTK

Trailing 12 months

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

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