DILUENT— 510(k) K831617

Substantially Equivalent

Omega Medical Diagnostics

FDA 510(k) clearance K831617 for DILUENT, Substantially Equivalent on 1983-06-16. Applicant: Omega Medical Diagnostics. Device class: 1.

Clearance details

Applicant: Omega Medical Diagnostics
Product code: Code GIF
Device class: Class 1
Regulation: 21 CFR 864.8200
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 GIF

K883989 — KVM ISOTONIC FLUSH SOLUTION1988-10-12
K883990 — KVM ISOTONIC DILUENT1988-10-12
K882490 — HYCEL QUICK-LYSING HEMOGLOBIN REAGENT1988-07-25
K882267 — SYSMEX QUICKLYSER-II (QLS-200A)1988-07-12
K881130 — CELL-DYN ISOTONIC DILUENT1988-03-31

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
K831618 — HEMOGLOBIN REAGENT1983-06-16

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