HGB3 (1:251)— 510(k) K802266

Substantially Equivalent

R&D Systems, Inc.

FDA 510(k) clearance K802266 for HGB3 (1:251), Substantially Equivalent on 1980-10-23. Applicant: R&D Systems, Inc.. Device class: 2.

Clearance details

Applicant: R&D Systems, Inc.
Product code: Code GKR
Device class: Class 2
Regulation: 21 CFR 864.5620
Advisory panel: Hematology
Date received: 1980-09-16
Decision date: 1980-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GKR

K201217 — HemoCue Hb 301 System2020-08-04
K200909 — Hemo Control (optional Add Pack Hemo Control DM)2020-06-12
K181751 — HemoCue Hb 801 System2019-02-01
K182298 — hemochroma PLUS System2018-11-16
K172173 — DiaSpect Tm, DiaSpect Tm Cuvettes2018-04-06

More clearances from R&D Systems, Inc.

K160606 — BC-5D Hematology Control2016-09-01
K130962 — R&D 5D RETIC HEMATOLOGY CONTROL2013-07-24
K101578 — R&D SYSTEMS BODY FLUID-I HEMATOLOGY CONTROL2011-04-28
K100050 — R & D SYSTEMS XERET HEMATOLOGY CONTROL2010-01-29
K091433 — R&D SYSTEMS TETIC-I PLUS HEMOTOLOGY CONTROL2009-10-28

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