NAO — Test, Carbohydrate Deficient Transferrin Class I

FDA Device Classification

FDA product code NAO covers "Test, Carbohydrate Deficient Transferrin", a Class I medical device regulated under 21 CFR 862.1360. Submissions are reviewed by the Clinical Chemistry panel. At least 3 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
NAO
Device Class
Class I
Regulation Number
862.1360
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K060677dade behringN LATEX CDTAugust 25, 2006
K001943sangui biotechCHRONALCO I.D.CDT (CARBOHYDRATE DEFICIENT TRANSFERRIN) ASSAYAugust 23, 2000
K992502axisAXIS %CDT TURBIDIMETRIC IMMUNOASSAYDecember 21, 1999