Cleared Traditional

SANGUI BIOTECH, INC. EPO (ERYTHROPOIETIN) ELISA KIT

K992799 · Sangui Biotech, Inc. · Hematology
Jun 2000
Decision
293d
Days
Class 2
Risk

About This 510(k) Submission

K992799 is an FDA 510(k) clearance for the SANGUI BIOTECH, INC. EPO (ERYTHROPOIETIN) ELISA KIT, a Assay, Erythropoietin (Class II — Special Controls, product code GGT), submitted by Sangui Biotech, Inc. (Santa Ana, US). The FDA issued a Cleared decision on June 7, 2000, 293 days after receiving the submission on August 19, 1999. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7250.

Submission Details

510(k) Number K992799 FDA.gov
FDA Decision Cleared SESE
Date Received August 19, 1999
Decision Date June 07, 2000
Days to Decision 293 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GGT — Assay, Erythropoietin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7250

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