AURAFLEX B2-MICROGLOBULIN— 510(k) K944846

Name: FDA 510(k) clearance K944846
Creator: U.S. Food and Drug Administration
Published: 1995-06-20

Substantially Equivalent

Organon Teknika Corp.

FDA 510(k) clearance K944846 for AURAFLEX B2-MICROGLOBULIN, Substantially Equivalent on 1995-06-20. Applicant: Organon Teknika Corp.. Device class: 2.

Clearance details

Applicant: Organon Teknika Corp.
Product code: Code JZG
Device class: Class 2
Regulation: 21 CFR 866.5630
Advisory panel: Immunology
Date received: 1994-09-30
Decision date: 1995-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Durham, NC, US

Download summary PDF View on FDA.gov ↗

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