ANTISERA TO HUMAN FREE LAMBDA LIGHT CH.— 510(k) K802284

Name: FDA 510(k) clearance K802284
Creator: U.S. Food and Drug Administration
Published: 1980-10-23

Substantially Equivalent

Kallestad Laboratories, Inc.

FDA 510(k) clearance K802284 for ANTISERA TO HUMAN FREE LAMBDA LIGHT CH., Substantially Equivalent on 1980-10-23. Applicant: Kallestad Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Kallestad Laboratories, Inc.
Product code: Code CZQ
Device class: Class 2
Regulation: 21 CFR 866.5150
Advisory panel: Immunology
Date received: 1980-09-19
Decision date: 1980-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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