ECLIPSE ICA TRIGLYCERIDES— 510(k) K905601

Substantially Equivalent

Biotope, Inc.

FDA 510(k) clearance K905601 for ECLIPSE ICA TRIGLYCERIDES, Substantially Equivalent on 1991-01-17. Applicant: Biotope, Inc.. Device class: 1.

Clearance details

Applicant: Biotope, Inc.
Product code: Code CDT
Device class: Class 1
Regulation: 21 CFR 862.1705
Advisory panel: Clinical Chemistry
Date received: 1990-12-13
Decision date: 1991-01-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redmond, WA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Biotope, Inc.

K905145 — ECLIPSE ICA CHOLESTEROL1991-02-26
K910256 — ECLIPSE ICA TSH1991-02-22
K910302 — ECLIPSE ICA ANALYZER1991-02-22
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.