IMMUNOCHEMICAL ASSAY OF C-REACTIVE PROTEIN— 510(k) K860679

Name: FDA 510(k) clearance K860679
Creator: U.S. Food and Drug Administration
Published: 1986-08-04

Substantially Equivalent for Some Indications

Orion Corp.

FDA 510(k) clearance K860679 for IMMUNOCHEMICAL ASSAY OF C-REACTIVE PROTEIN, Substantially Equivalent for Some Indications on 1986-08-04. Applicant: Orion Corp.. Device class: 2.

Clearance details

Applicant: Orion Corp.
Product code: Code DCN
Device class: Class 2
Regulation: 21 CFR 866.5270
Advisory panel: Immunology
Date received: 1986-02-25
Decision date: 1986-08-04
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: 20101 Turku, FI

Download summary PDF View on FDA.gov ↗

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