Chronalco I.D.Cdt (Carbohydrate Deficient Transferrin) Assay

FDA 510(k) K001943 · Sangui Biotech, Inc.

Substantially Equivalent

510(k) numberK001943

Submission

Device name
Chronalco I.D.Cdt (Carbohydrate Deficient Transferrin) Assay
Applicant
Sangui Biotech, Inc.
Santa Ana, CA, US
Received
June 26, 2000
Decision date
August 23, 2000
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NAO – Test, Carbohydrate Deficient Transferrin
Device class
Class I (low risk)
Regulation
21 CFR 862.1360
Specialty
Clinical Chemistry

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Questions and answers

When was Chronalco I.D.Cdt (Carbohydrate Deficient Transferrin) Assay cleared by the FDA?

Chronalco I.D.Cdt (Carbohydrate Deficient Transferrin) Assay (K001943) received a 510(k) decision of Substantially Equivalent on August 23, 2000, 58 days after the submission was received.

What is the product code of K001943?

The FDA product code is NAO – Test, Carbohydrate Deficient Transferrin, a Class I (low risk) device regulated under 21 CFR 862.1360.