SANGUI BIOTECH, INC. EPO (ERYTHROPOIETIN) ELISA KIT— 510(k) K992799

Name: FDA 510(k) clearance K992799
Creator: U.S. Food and Drug Administration
Published: 2000-06-07

Substantially Equivalent

Sangui Biotech, Inc.

FDA 510(k) clearance K992799 for SANGUI BIOTECH, INC. EPO (ERYTHROPOIETIN) ELISA KIT, Substantially Equivalent on 2000-06-07. Applicant: Sangui Biotech, Inc.. Device class: 2.

Clearance details

Applicant: Sangui Biotech, Inc.
Product code: Code GGT
Device class: Class 2
Regulation: 21 CFR 864.7250
Advisory panel: Hematology
Date received: 1999-08-19
Decision date: 2000-06-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

Download summary PDF View on FDA.gov ↗

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