ANTISERA, RHODAMINE CONJUGATED FRAGMENT— 510(k) K781951

Name: FDA 510(k) clearance K781951
Creator: U.S. Food and Drug Administration
Published: 1979-02-16

Substantially Equivalent

Kallestad Laboratories, Inc.

FDA 510(k) clearance K781951 for ANTISERA, RHODAMINE CONJUGATED FRAGMENT, Substantially Equivalent on 1979-02-16. Applicant: Kallestad Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Kallestad Laboratories, Inc.
Product code: Code DCE
Device class: Class 1
Regulation: 21 CFR 866.5520
Advisory panel: Immunology
Date received: 1978-11-21
Decision date: 1979-02-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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