← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS III

LOK — Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

DEVICE CLASS
Class III
MEDICAL SPECIALTY
Unknown
REVIEW PANEL
IM
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
4
510(K)/PMA CLEARANCES
pma: 4
0
RECALL ENTRIES

Recent clearances

P120008Abbott Laboratories · pma2026-05-11
P930036Siemens Healthcare Diagnostics, Inc. · pma2026-05-11
P010007Siemens Healthcare Diagnostics, Inc. · pma2026-04-21
P980041Beckman Coulter, Inc. · pma2025-11-03

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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