ECLIPSE ICA CHOLESTEROL— 510(k) K905145

Substantially Equivalent

Biotope, Inc.

FDA 510(k) clearance K905145 for ECLIPSE ICA CHOLESTEROL, Substantially Equivalent on 1991-02-26. Applicant: Biotope, Inc.. Device class: 1.

Clearance details

Applicant: Biotope, Inc.
Product code: Code CHH
Device class: Class 1
Regulation: 21 CFR 862.1175
Advisory panel: Clinical Chemistry
Date received: 1990-11-15
Decision date: 1991-02-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redmond, WA, US

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 Biotope, Inc.

K910256 — ECLIPSE ICA TSH1991-02-22
K910302 — ECLIPSE ICA ANALYZER1991-02-22
K905601 — ECLIPSE ICA TRIGLYCERIDES1991-01-17
K905719 — ECLIPSE ICA DIGOXIN1991-01-17
K905602 — ECLIPSE ICA BUN1991-01-16

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