HEMOCUE PHOTOMETER TECHNICAL MANUAL— 510(k) K832020

Name: FDA 510(k) clearance K832020
Creator: U.S. Food and Drug Administration
Published: 1983-10-28

Substantially Equivalent

Aktiebolaget Leo Diagnostics

FDA 510(k) clearance K832020 for HEMOCUE PHOTOMETER TECHNICAL MANUAL, Substantially Equivalent on 1983-10-28. Applicant: Aktiebolaget Leo Diagnostics. Device class: 2.

Clearance details

Applicant: Aktiebolaget Leo Diagnostics
Product code: Code GKR
Device class: Class 2
Regulation: 21 CFR 864.5620
Advisory panel: Hematology
Date received: 1983-06-15
Decision date: 1983-10-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GKR

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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

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