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FDA Product Code

FDA Product Code NAO — Clearance Directory

Device Class
Class I
Assigned Panel
Clinical Chemistry
21 CFR Citation
862.1360

510(k) Clearances — 3 records

K-Number Device Name Applicant Decision Date Clearance Type Summary
K060677 N LATEX CDT Dade Behring, Inc. 2006-08-25 Traditional PDF ↗
K001943 CHRONALCO I.D.CDT (CARBOHYDRATE DEFICIENT TRANSFERRIN) ASSAY Sangui Biotech, Inc. 2000-08-23 Traditional PDF ↗
K992502 AXIS %CDT TURBIDIMETRIC IMMUNOASSAY Axis 1999-12-21 Traditional PDF ↗

Product code NAO · Class I · Clinical Chemistry. Data: openFDA.