IMMUNO-CELL IMMUNO-SEP KIT— 510(k) K812411

Name: FDA 510(k) clearance K812411
Creator: U.S. Food and Drug Administration
Published: 1981-11-10

Substantially Equivalent

Kallestad Laboratories, Inc.

FDA 510(k) clearance K812411 for IMMUNO-CELL IMMUNO-SEP KIT, Substantially Equivalent on 1981-11-10. Applicant: Kallestad Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Kallestad Laboratories, Inc.
Product code: Code JCF
Device class: Class 1
Regulation: 21 CFR 864.8500
Advisory panel: Hematology
Date received: 1981-08-21
Decision date: 1981-11-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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