ECLIPSE ICA DIGOXIN— 510(k) K905719

Substantially Equivalent

Biotope, Inc.

FDA 510(k) clearance K905719 for ECLIPSE ICA DIGOXIN, Substantially Equivalent on 1991-01-17. Applicant: Biotope, Inc.. Device class: 2.

Clearance details

Applicant: Biotope, Inc.
Product code: Code DPO
Device class: Class 2
Regulation: 21 CFR 862.3320
Advisory panel: Clinical Toxicology
Date received: 1990-12-21
Decision date: 1991-01-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redmond, WA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DPO

K914833 — IMMULITE DIGOXIN1991-11-22
K864449 — DIGOXIN/RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT1987-02-02
K833842 — RIA COAT DIGOXIN1984-01-17
K832163 — SOPHEIA DIGOXIN EIA KIT1983-08-12
K830962 — IMMUCHEM COVALENT-COAT RIA KIT1983-05-04

More clearances from Biotope, Inc.

K905145 — ECLIPSE ICA CHOLESTEROL1991-02-26
K910256 — ECLIPSE ICA TSH1991-02-22
K910302 — ECLIPSE ICA ANALYZER1991-02-22
K905601 — ECLIPSE ICA TRIGLYCERIDES1991-01-17
K905602 — ECLIPSE ICA BUN1991-01-16

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