CHOLESTEROL TEST KIT— 510(k) K895951

Substantially Equivalent

Elite Technology, Inc.

FDA 510(k) clearance K895951 for CHOLESTEROL TEST KIT, Substantially Equivalent on 1990-02-16. Applicant: Elite Technology, Inc.. Device class: 1.

Clearance details

Applicant: Elite Technology, Inc.
Product code: Code CHH
Device class: Class 1
Regulation: 21 CFR 862.1175
Advisory panel: Clinical Chemistry
Date received: 1989-10-11
Decision date: 1990-02-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Canada M9w 5p1, CA

Download summary PDF View on FDA.gov ↗

Recent devices under product code CHH

K251091 — Lipids2025-12-30
K232404 — CHOLESTEROL; HDL-cholesterol; LDL-cholesterol; TRIGLYCERIDES2024-08-09
K203597 — Cholesterol22022-06-30
K190490 — VITROS XT Chemistry Products TRIG-CHOL Slides2019-03-27
K181373 — Extended Lipid Panel Assay2018-10-18

More clearances from Elite Technology, Inc.

K900733 — PROTEIN TEST FOR URINE AND CSF1990-07-10
K901001 — URIC ACID TEST KIT1990-05-23
K901090 — ELITECH GAMMA GT TEST KIT1990-03-29
K895952 — TRIGLYCERIDES TEST KIT1990-01-11

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