510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K981297Substantially Equivalent

Immulite Om-Ma, Models Lkopz, Lkop1, Lkop5

Siemens Healthcare Diagnostics Inc., Los Angeles CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K981297 is the FDA 510(k) clearance record for IMMULITE OM-MA, MODELS LKOPZ, LKOP1, LKOP5, a class II device, cleared for Diagnostic Products Corp. 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 one recall naming K981297.

Clearance record

Decision date
Received
(163 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
Diagnostic Products Corp. 5700 W. 96th St., Los Angeles CA
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