THE GAMMA-B ANTI-DS DNA KIT & OPTIONAL CONTROLS— 510(k) K872085

Name: FDA 510(k) clearance K872085
Creator: U.S. Food and Drug Administration
Published: 1987-09-01

Substantially Equivalent

Immunodiagnostics, Ltd.

FDA 510(k) clearance K872085 for THE GAMMA-B ANTI-DS DNA KIT & OPTIONAL CONTROLS, Substantially Equivalent on 1987-09-01. Applicant: Immunodiagnostics, Ltd.. Device class: 2.

Clearance details

Applicant: Immunodiagnostics, Ltd.
Product code: Code LSW
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 1987-06-01
Decision date: 1987-09-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: England, U.K., GB

Download summary PDF View on FDA.gov ↗

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