CHRONALCO I.D.CDT (CARBOHYDRATE DEFICIENT TRANSFERRIN) ASSAY— 510(k) K001943

Name: FDA 510(k) clearance K001943
Creator: U.S. Food and Drug Administration
Published: 2000-08-23

Substantially Equivalent

Sangui Biotech, Inc.

FDA 510(k) clearance K001943 for CHRONALCO I.D.CDT (CARBOHYDRATE DEFICIENT TRANSFERRIN) ASSAY, Substantially Equivalent on 2000-08-23. Applicant: Sangui Biotech, Inc.. Device class: 1.

Clearance details

Applicant: Sangui Biotech, Inc.
Product code: Code NAO
Device class: Class 1
Regulation: 21 CFR 862.1360
Advisory panel: Clinical Chemistry
Date received: 2000-06-26
Decision date: 2000-08-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

Download summary PDF View on FDA.gov ↗

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