KALLESTAD'S ENDOPLATE FACTOR B TEST— 510(k) K811740

Name: FDA 510(k) clearance K811740
Creator: U.S. Food and Drug Administration
Published: 1981-07-16

Substantially Equivalent

Kallestad Laboratories, Inc.

FDA 510(k) clearance K811740 for KALLESTAD'S ENDOPLATE FACTOR B TEST, Substantially Equivalent on 1981-07-16. Applicant: Kallestad Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Kallestad Laboratories, Inc.
Product code: Code JZH
Device class: Class 2
Regulation: 21 CFR 866.5320
Advisory panel: Immunology
Date received: 1981-06-19
Decision date: 1981-07-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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