MICROALBUMINURIA ASSAY— 510(k) K862671

Substantially Equivalent

Orion Corp.

FDA 510(k) clearance K862671 for MICROALBUMINURIA ASSAY, Substantially Equivalent on 1986-09-18. Applicant: Orion Corp.. Device class: 2.

Clearance details

Applicant: Orion Corp.
Product code: Code DCF
Device class: Class 2
Regulation: 21 CFR 866.5040
Advisory panel: Immunology
Date received: 1986-07-14
Decision date: 1986-09-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: 20101 Turku, FI

Download summary PDF View on FDA.gov ↗

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