IGG IMMUNOTURBIDIMETRIC & CALIBRATOR— 510(k) K955798

Name: FDA 510(k) clearance K955798
Creator: U.S. Food and Drug Administration
Published: 1996-04-05

Substantially Equivalent

Randox Laboratories, Ltd.

FDA 510(k) clearance K955798 for IGG IMMUNOTURBIDIMETRIC & CALIBRATOR, Substantially Equivalent on 1996-04-05. Applicant: Randox Laboratories, Ltd.. Device class: 2.

Clearance details

Applicant: Randox Laboratories, Ltd.
Product code: Code DEW
Device class: Class 2
Regulation: 21 CFR 866.5510
Advisory panel: Immunology
Date received: 1995-12-22
Decision date: 1996-04-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crumlin, IE

Download summary PDF View on FDA.gov ↗

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