IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN M— 510(k) K884147

Name: FDA 510(k) clearance K884147
Creator: U.S. Food and Drug Administration
Published: 1988-10-27

Substantially Equivalent

Orion Diagnostica, Inc.

FDA 510(k) clearance K884147 for IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN M, Substantially Equivalent on 1988-10-27. Applicant: Orion Diagnostica, Inc.. Device class: 2.

Clearance details

Applicant: Orion Diagnostica, Inc.
Product code: Code DFT
Device class: Class 2
Regulation: 21 CFR 866.5550
Advisory panel: Immunology
Date received: 1988-10-03
Decision date: 1988-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: 02101 Espoo, FI

Download summary PDF View on FDA.gov ↗

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K884074 — IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN G1988-10-27
K884040 — IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN A1988-10-19

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