510(k) K992502

Device: AXIS %CDT TURBIDIMETRIC IMMUNOASSAY
Applicant: AXIS
510(k) number: K992502
Product code: NAO
Decision: Substantially Equivalent (SESE)
Decision date: 1999-12-21
Date received: 1999-07-26
Regulation: 862.1360
Classification name: Test, Carbohydrate Deficient Transferrin
Medical specialty: Clinical Chemistry
Review panel: Clinical Chemistry
Device class: 1
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: RONALD G LEONARDI
Address: P.O. Box 262069 San Diego CA US 92196 92196

FDA Registration Numbers#

9610806
3014325803
8023024

Source Documents#

Other 510(k) Records For Product Code NAO #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K060677	N LATEX CDT	Dade Behring, Inc.	2006-08-25
K001943	CHRONALCO I.D.CDT (CARBOHYDRATE DEFICIENT TRANSFERRIN) ASSAY	Sangui Biotech, Inc.	2000-08-23

Legacy Summary#

summary

FDA Review#

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