← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

NBW — System, Test, Blood Glucose, Over The Counter

DEVICE CLASS
Class II
REGULATION
21 CFR 862.1345
MEDICAL SPECIALTY
Clinical Chemistry
REVIEW PANEL
CH
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
4
510(K)/PMA CLEARANCES
510k: 4
0
RECALL ENTRIES

Recent clearances

K250085ACON Laboratories, Inc. · 510k2025-10-10
K243060Guangdong Transtek Medical Electronics Co., Ltd. · 510k2025-01-30
K240637Bionime Corporation · 510k2024-11-04
K240640Sejoy Biomedical Co., Ltd. · 510k2024-10-08

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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