Product code NAO— Clinical Chemistry

AXIS %CDT TURBIDIMETRIC IMMUNOASSAY

Classification name: Test, Carbohydrate Deficient Transferrin
Device class: Class 1
Regulation: 21 CFR 862.1360
Advisory panel: Clinical Chemistry
Total cleared: 3
First cleared: 1999-12-21
Most recent: 2006-08-25

Market context for product code NAO

FDA has cleared 3 devices under product code NAO between 1999 and 2006, filed by 3 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

20061 clearance
20001 clearance
19991 clearance

Top applicants under product code NAO

Sangui Biotech, Inc.1 clearance
Dade Behring, Inc.1 clearance
Axis1 clearance

Recent clearances under product code NAO

K060677 — N LATEX CDTDade Behring, Inc.·2006-08-25
K001943 — CHRONALCO I.D.CDT (CARBOHYDRATE DEFICIENT TRANSFERRIN) ASSAYSangui Biotech, Inc.·2000-08-23
K992502 — AXIS %CDT TURBIDIMETRIC IMMUNOASSAYAxis·1999-12-21

Data sourced from openFDA. This site is unofficial and independent of the FDA.