STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM— 510(k) K081719

Name: FDA 510(k) clearance K081719
Creator: U.S. Food and Drug Administration
Published: 2008-07-18

Substantially Equivalent

Stanbio Laboratory

FDA 510(k) clearance K081719 for STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM, Substantially Equivalent on 2008-07-18. Applicant: Stanbio Laboratory. Device class: 2.

Clearance details

Applicant: Stanbio Laboratory
Product code: Code GKR
Device class: Class 2
Regulation: 21 CFR 864.5620
Advisory panel: Hematology
Date received: 2008-06-18
Decision date: 2008-07-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Boerne, TX, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K081719

K-number listed on FDA's recall record

Z-2926-2018 — Stanbio AC power adapter for the HemoPoint H2 meter, Model G3000 series. The firm name on the label for the HemoPoint H2 shows Manufactured by EKF-diagnostic GmbH, Germany.Class II·Terminated·Stanbio Laboratory, LP·20180208

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K081719.

Data sourced from openFDA. This site is unofficial and independent of the FDA.