KALLESTAD ANTISERA TO GENTAMICIN— 510(k) K812050

Name: FDA 510(k) clearance K812050
Creator: U.S. Food and Drug Administration
Published: 1981-08-03

Substantially Equivalent

Kallestad Laboratories, Inc.

FDA 510(k) clearance K812050 for KALLESTAD ANTISERA TO GENTAMICIN, Substantially Equivalent on 1981-08-03. Applicant: Kallestad Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Kallestad Laboratories, Inc.
Product code: Code DJI
Device class: Class 2
Regulation: 21 CFR 862.3450
Advisory panel: Clinical Toxicology
Date received: 1981-07-21
Decision date: 1981-08-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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