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

Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)

21 CFR 866.6010 / Immunology
FDA source (opens on fda.gov)

LTK is the FDA product code for Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125), a class II device type, regulated under 21 CFR 866.6010. As of , FDA records hold 26 510(k) clearances under this code, the most recent dated , and 8 recalls.

Classification record

Product code
LTK
Device name
Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
Regulation
21 CFR 866.6010
Device class
Class II
Review panel
Immunology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
26
Ingested recalls
8

Clearances, product code LTK

By decision year
26 clearances under product code LTK with a decision year between 1997 and 2024, 1998 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code LTK by decision year
YearClearances
19973
19984
19993
20024
20031
20041
20071
20092
20111
20152
20201
20221
20231
20241

Applicants with the most clearances

Product code LTK
Applicants holding the most 510(k) clearances under product code LTK
ApplicantClearances
Siemens Healthcare Diagnostics Inc.8
Bayer Corp.3
Boehringer Mannheim Corp.2
Fujirebio Diagnostics, Inc.2
Ortho-Clinical Diagnostics, Inc.2
Tosoh Medics, Inc.2
bioMerieux, Inc.2
Abbott Diagnostics1
Abbott Medical1
Bayer Diagnostics Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 21 companies shown, in name order