← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

CGX — Alkaline Picrate, Colorimetry, Creatinine

DEVICE CLASS
Class II
REGULATION
21 CFR 862.1225
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

K252206Nova Biomedical Corporation · 510k2026-01-09
K251058Truvian Health · 510k2025-11-26
K242685Siemens Healthcare Diagnostics, Inc. · 510k2024-12-04
K221813Nova Biomedical Corporation · 510k2024-11-19

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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