72 DETERM. SIZE RADIAL IMMUNO. TEST HUMAN CERULOPL— 510(k) K850682

Name: FDA 510(k) clearance K850682
Creator: U.S. Food and Drug Administration
Published: 1985-11-25

Substantially Equivalent

Kent Laboratories, Inc.

FDA 510(k) clearance K850682 for 72 DETERM. SIZE RADIAL IMMUNO. TEST HUMAN CERULOPL, Substantially Equivalent on 1985-11-25. Applicant: Kent Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Kent Laboratories, Inc.
Product code: Code DDB
Device class: Class 2
Regulation: 21 CFR 866.5210
Advisory panel: Immunology
Date received: 1985-02-21
Decision date: 1985-11-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redmond, WA, US

Download summary PDF View on FDA.gov ↗

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