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FDA PRODUCT CODE · CLASS II

PDJ — Hemoglobin A1c Test System

Quantitative determination of Hemoglobin A1c to aid in the diagnosis of diabetes.

DEVICE CLASS
Class II
REGULATION
21 CFR 862.1373
MEDICAL SPECIALTY
Clinical Chemistry
REVIEW PANEL
CH
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
3
510(K)/PMA CLEARANCES
510k: 3
0
RECALL ENTRIES

Recent clearances

K252749Shanghai Medconn Medical Technology Co., Ltd. · 510k2026-01-06
K250073Tosoh Bioscience, Inc. · 510k2025-10-03
K242911Shanghai Medconn Medical Technology Co., Ltd. · 510k2025-06-20

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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