← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

LCX — Kit, Test, Pregnancy, Hcg, Over The Counter

DEVICE CLASS
Class II
REGULATION
21 CFR 862.1155
MEDICAL SPECIALTY
Clinical Chemistry
REVIEW PANEL
CH
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
7
510(K)/PMA CLEARANCES
510k: 7
0
RECALL ENTRIES

Recent clearances

K251040Guangzhou Decheng Biotechnology Co., Ltd. · 510k2025-09-09
K251053Hangzhou AllTest Biotech Co., Ltd. · 510k2025-07-15
K250117Assure Tech., LLC · 510k2025-02-13
K242135Nanjing Synthgene Medical Technology Co., Ltd. · 510k2025-01-31
K243573Assure Tech., LLC · 510k2025-01-15
K241394Andon Health Co, Ltd. · 510k2024-12-20
K240242Anhui Deepblue Medical Technology Co., Ltd. · 510k2024-10-11

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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