← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS III

MTG — Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

DEVICE CLASS
Class III
MEDICAL SPECIALTY
Unknown
REVIEW PANEL
IM
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
7
510(K)/PMA CLEARANCES
pma: 7
0
RECALL ENTRIES

Recent clearances

P250026Siemens Healthcare Diagnostics, Inc. · pma2026-05-11
P060005Siemens Medical Solutions Diagnostics Limited · pma2026-04-21
P980007Abbott Laboratories · pma2026-02-12
P950021Siemens Healthcare Diagnostics · pma2025-07-16
P970038Beckman Coulter, Inc. · pma2025-05-15
P020027Siemens Healthcare Diagnostics · pma2025-02-24
P000027Roche Diagnostics Corp. · pma2024-10-17

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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