HEMOCUE HEMOGLOBIN 201 + SYSTEM ARTICLE 121704— 510(k) K032203

Name: FDA 510(k) clearance K032203
Creator: U.S. Food and Drug Administration
Published: 2003-08-25

Substantially Equivalent

Hemocue, Inc.

FDA 510(k) clearance K032203 for HEMOCUE HEMOGLOBIN 201 + SYSTEM ARTICLE 121704, Substantially Equivalent on 2003-08-25. Applicant: Hemocue, Inc.. Device class: 2.

Clearance details

Applicant: Hemocue, Inc.
Product code: Code GKR
Device class: Class 2
Regulation: 21 CFR 864.5620
Advisory panel: Hematology
Date received: 2003-07-18
Decision date: 2003-08-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Potomac, MD, US

Download summary PDF View on FDA.gov ↗

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K181751 — HemoCue Hb 801 System2019-02-01
K182298 — hemochroma PLUS System2018-11-16
K172173 — DiaSpect Tm, DiaSpect Tm Cuvettes2018-04-06

More clearances from Hemocue, Inc.

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K041234 — HEMOCUE HEMOGLOBIN 201DM ANALYZING SYSTEM2004-06-10
K041230 — CLINICAL LABORATORY ANALYZING SYSTEM2004-05-20
K020935 — HEMOCUE GLUCOSE 201 SYSTEM, ARTICLE NUMBER 1207062002-04-03
K962415 — HEMOCUE B-GLCOSE SYSTEM1996-10-15
K961312 — HEMOCUE B-HEMOGLOBIN SYSTEM1996-09-24

Recalls naming K032203

K-number listed on FDA's recall record

Z-0101-2014 — HemoCue¿ Hb 201 Microcuvettes, carton/4 boxes/25 pouches of Microcuvettes, HemoCue AB Angelholm, SwedenClass II·Terminated·HemoCue AB·20130725

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K032203.

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