QUANTITOPE 125-I GENTAMICIN RIA KIT— 510(k) K780323

Name: FDA 510(k) clearance K780323
Creator: U.S. Food and Drug Administration
Published: 1978-03-17

Substantially Equivalent

Kallestad Laboratories, Inc.

FDA 510(k) clearance K780323 for QUANTITOPE 125-I GENTAMICIN RIA KIT, Substantially Equivalent on 1978-03-17. Applicant: Kallestad Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Kallestad Laboratories, Inc.
Product code: Code DJB
Device class: Class 2
Regulation: 21 CFR 862.3450
Advisory panel: Clinical Toxicology
Date received: 1978-02-27
Decision date: 1978-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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