NSI REAGENT SYSTEM FOR ORTHO ELT-8 HEMA— 510(k) K801346

Name: FDA 510(k) clearance K801346
Creator: U.S. Food and Drug Administration
Published: 1980-08-12

Substantially Equivalent

Nobel Scientific Industries, Inc.

FDA 510(k) clearance K801346 for NSI REAGENT SYSTEM FOR ORTHO ELT-8 HEMA, Substantially Equivalent on 1980-08-12. Applicant: Nobel Scientific Industries, Inc.. Device class: 1.

Clearance details

Applicant: Nobel Scientific Industries, Inc.
Product code: Code GIF
Device class: Class 1
Regulation: 21 CFR 864.8200
Advisory panel: Hematology
Date received: 1980-06-09
Decision date: 1980-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GIF

view all

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 Nobel Scientific Industries, Inc.

view all

K854717 — NSI ASTRA TM TOTAL PROTEIN REAGENT KIT, NSI #79281986-01-14
K854716 — NSI ASTRA TM CALCIUM REAGENT KIT NSI ITEM # 79091986-01-07
K854718 — NSI ASTRA TM ALBUMIN REAGENT KIT NSI ITEM # 79261985-12-19
K850944 — NSI LYSING-D REAGENT -4000 ML1985-03-29
K844782 — NSI ELT-D DILUTING FLUID 4000ML1985-03-05

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