QUANTIMETRIC PLUS IGM REAGENT KIT— 510(k) K855010

Name: FDA 510(k) clearance K855010
Creator: U.S. Food and Drug Administration
Published: 1986-02-28

Substantially Equivalent

Kallestad Laboratories, Inc.

FDA 510(k) clearance K855010 for QUANTIMETRIC PLUS IGM REAGENT KIT, Substantially Equivalent on 1986-02-28. Applicant: Kallestad Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Kallestad Laboratories, Inc.
Product code: Code DFT
Device class: Class 2
Regulation: 21 CFR 866.5550
Advisory panel: Immunology
Date received: 1985-12-16
Decision date: 1986-02-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chaska, MN, US

Download summary PDF View on FDA.gov ↗

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