IMMUNOCHEMICAL ASSAY OF APOLIPOPROTEIN A1— 510(k) K861883

Name: FDA 510(k) clearance K861883
Creator: U.S. Food and Drug Administration
Published: 1986-10-29

Substantially Equivalent

Orion Corp.

FDA 510(k) clearance K861883 for IMMUNOCHEMICAL ASSAY OF APOLIPOPROTEIN A1, Substantially Equivalent on 1986-10-29. Applicant: Orion Corp.. Device class: 1.

Clearance details

Applicant: Orion Corp.
Product code: Code MSJ
Device class: Class 1
Regulation: 21 CFR 862.1475
Advisory panel: Clinical Chemistry
Date received: 1986-05-15
Decision date: 1986-10-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: 20101 Turku, FI

Download summary PDF View on FDA.gov ↗

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