QVANTIMETRIC 2KAPPA AND LAMBDA TEST KIT— 510(k) K852999

Name: FDA 510(k) clearance K852999
Creator: U.S. Food and Drug Administration
Published: 1985-10-21

Substantially Equivalent

Kallestad Laboratories, Inc.

FDA 510(k) clearance K852999 for QVANTIMETRIC 2KAPPA AND LAMBDA TEST KIT, Substantially Equivalent on 1985-10-21. Applicant: Kallestad Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Kallestad Laboratories, Inc.
Product code: Code DEH
Device class: Class 2
Regulation: 21 CFR 866.5550
Advisory panel: Immunology
Date received: 1985-07-15
Decision date: 1985-10-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chaska, MN, US

Download summary PDF View on FDA.gov ↗

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