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FDA PRODUCT CODE · CLASS II

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

DEVICE CLASS
Class II
REGULATION
21 CFR 866.6010
MEDICAL SPECIALTY
Immunology
REVIEW PANEL
IM
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
3
510(K)/PMA CLEARANCES
pma: 2 · 510k: 1
0
RECALL ENTRIES

Recent clearances

P000027Roche Diagnostics Corp. · pma2026-04-29
K251630Siemens Healthcare Diagnostics, Inc. · 510k2026-01-05
P000021Siemens Healthcare Diagnostics · pma2025-05-22

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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