510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K023597Substantially Equivalent

Access Ov Monitor Immunoenzymetric Assay

Siemens Healthcare Diagnostics Inc., San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K023597 is the FDA 510(k) clearance record for ACCESS OV MONITOR IMMUNOENZYMETRIC ASSAY, a class II device, cleared for Beckman Coulter, Inc. on under FDA product code LTK (Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)). FDA records list 1,204 510(k) clearances for Siemens Healthcare Diagnostics Inc., from to . As of , FDA records show no recalls naming K023597.

Clearance record

Decision date
Received
(44 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
Beckman Coulter, Inc. 7330 Carroll Rd., San Diego CA
510(k) summary
Summary PDF
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 November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LTK, 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