LTJClass II

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

21 CFR 866.6010 / Immunology

LTJ is the FDA product code for Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers, a class II device type, regulated under 21 CFR 866.6010. As of 2026-09-10, FDA records hold 34 510(k) clearances under this code, the most recent dated 2026-01-05, and 12 recalls.

Classification record

Product code: LTJ
Device name: Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
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: 34
Ingested recalls: 12

Clearances, product code LTJ

By decision year

34 clearances under product code LTJ with a decision year between 1997 and 2026, 1998 the highest year at 11.

Show the numbers

510(k) clearances under FDA product code LTJ by decision year
Year	Clearances
1997	6
1998	11
1999	2
2000	7
2001	2
2002	2
2003	1
2013	1
2017	1
2026	1

Applicants with the most clearances

Product code LTJ

Applicants holding the most 510(k) clearances under product code LTJ
Applicant	Clearances
Siemens Healthcare Diagnostics Inc.	6
Boehringer Mannheim Corp.	5
Bayer Corp.	2
Bayer Corp.	2
Diagnostic Systems Laboratories, Inc.	2
Oncogene Science, Inc.	2
Ortho-Clinical Diagnostics, Inc.	2
Qualisys Diagnostics, Inc.	2
Bayer Diagnostics Corp.	1
Beckman Instruments, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 22 companies shown, in name order