ANTISERA TO HUMAN FRAGMENT— 510(k) K790711

Name: FDA 510(k) clearance K790711
Creator: U.S. Food and Drug Administration
Published: 1979-09-04

Substantially Equivalent

Kent Laboratories, Inc.

FDA 510(k) clearance K790711 for ANTISERA TO HUMAN FRAGMENT, Substantially Equivalent on 1979-09-04. Applicant: Kent Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Kent Laboratories, Inc.
Product code: Code DFK
Device class: Class 1
Regulation: 21 CFR 866.5520
Advisory panel: Immunology
Date received: 1979-04-12
Decision date: 1979-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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