HEMOGLOBIN REAGENT— 510(k) K831618

Substantially Equivalent

Omega Medical Diagnostics

FDA 510(k) clearance K831618 for HEMOGLOBIN REAGENT, Substantially Equivalent on 1983-06-16. Applicant: Omega Medical Diagnostics. Device class: 2.

Clearance details

Applicant: Omega Medical Diagnostics
Product code: Code GKR
Device class: Class 2
Regulation: 21 CFR 864.5620
Advisory panel: Hematology
Date received: 1983-05-19
Decision date: 1983-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GKR

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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 Omega Medical Diagnostics

K832182 — LYSING REAGENT1983-08-12
K831619 — SODIUM HYPOCHLORITE 7%1983-07-28
K831620 — SODIUM HYPOCHLORITE 3%1983-07-28
K831617 — DILUENT1983-06-16

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