RADIOASSAY, CONTROL SERUM I, II, III— 510(k) K790298

Name: FDA 510(k) clearance K790298
Creator: U.S. Food and Drug Administration
Published: 1979-04-04

Substantially Equivalent

Kallestad Laboratories, Inc.

FDA 510(k) clearance K790298 for RADIOASSAY, CONTROL SERUM I, II, III, Substantially Equivalent on 1979-04-04. Applicant: Kallestad Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Kallestad Laboratories, Inc.
Product code: Code DGR
Device class: Class 1
Regulation: 21 CFR 866.5700
Advisory panel: Immunology
Date received: 1979-02-12
Decision date: 1979-04-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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