HUMAN PREALBUMIN RADIAL IMMUNODIFFUSION KIT— 510(k) K951966

Name: FDA 510(k) clearance K951966
Creator: U.S. Food and Drug Administration
Published: 1995-06-01

Substantially Equivalent

Kent Laboratories, Inc.

FDA 510(k) clearance K951966 for HUMAN PREALBUMIN RADIAL IMMUNODIFFUSION KIT, Substantially Equivalent on 1995-06-01. Applicant: Kent Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Kent Laboratories, Inc.
Product code: Code JZJ
Device class: Class 1
Regulation: 21 CFR 866.5060
Advisory panel: Immunology
Date received: 1995-04-27
Decision date: 1995-06-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redmond, WA, US

Download summary PDF View on FDA.gov ↗

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