CLINISTAT ALBUMIN REAGENT TEST— 510(k) K896910

Name: FDA 510(k) clearance K896910
Creator: U.S. Food and Drug Administration
Published: 1990-01-18

Substantially Equivalent

Miles Diagnostics Div.

FDA 510(k) clearance K896910 for CLINISTAT ALBUMIN REAGENT TEST, Substantially Equivalent on 1990-01-18. Applicant: Miles Diagnostics Div.. Device class: 2.

Clearance details

Applicant: Miles Diagnostics Div.
Product code: Code CIX
Device class: Class 2
Regulation: 21 CFR 862.1035
Advisory panel: Clinical Chemistry
Date received: 1989-12-11
Decision date: 1990-01-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elkhart, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CIX

view all

K251157 — Core Metabolic2026-01-09
K203248 — Albumin BCG22021-11-23
K200898 — Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medicon Hellas Urea Nitrogen, Medicon Hellas Glucose, Medicon Hellas Total Bilirubin, Medicon Hellas Direct Bilirubin2021-09-21
K191316 — VITROS XT Chemistry Products ALB-TP Slides2019-06-07
K170901 — ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA4002018-04-13

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