CYTOTECH RUBELLA IGG ENZYME IMMUNOASSAY— 510(k) K864315

Name: FDA 510(k) clearance K864315
Creator: U.S. Food and Drug Administration
Published: 1987-02-02

Substantially Equivalent

Cytotech, Inc.

FDA 510(k) clearance K864315 for CYTOTECH RUBELLA IGG ENZYME IMMUNOASSAY, Substantially Equivalent on 1987-02-02. Applicant: Cytotech, Inc.. Device class: 2.

Clearance details

Applicant: Cytotech, Inc.
Product code: Code LFX
Device class: Class 2
Regulation: 21 CFR 866.3510
Advisory panel: Microbiology
Date received: 1986-11-03
Decision date: 1987-02-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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