RUBENOSTIKA IGG MICROELISA SYSTEM— 510(k) K911393

Name: FDA 510(k) clearance K911393
Creator: U.S. Food and Drug Administration
Published: 1991-04-29

Substantially Equivalent

Organon Teknika Corp.

FDA 510(k) clearance K911393 for RUBENOSTIKA IGG MICROELISA SYSTEM, Substantially Equivalent on 1991-04-29. Applicant: Organon Teknika Corp.. Device class: 2.

Clearance details

Applicant: Organon Teknika Corp.
Product code: Code LFX
Device class: Class 2
Regulation: 21 CFR 866.3510
Advisory panel: Microbiology
Date received: 1991-03-29
Decision date: 1991-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Durham, NC, US

Download summary PDF View on FDA.gov ↗

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