Cleared Special

STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM

K081719 · Stanbio Laboratory · Hematology
Jul 2008
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K081719 is an FDA 510(k) clearance for the STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM, a System, Hemoglobin, Automated (Class II — Special Controls, product code GKR), submitted by Stanbio Laboratory (Boerne, US). The FDA issued a Cleared decision on July 18, 2008, 30 days after receiving the submission on June 18, 2008. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5620.

Submission Details

510(k) Number K081719 FDA.gov
FDA Decision Cleared SESE
Date Received June 18, 2008
Decision Date July 18, 2008
Days to Decision 30 days
Submission Type Special
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GKR — System, Hemoglobin, Automated
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5620