QUANTIMETRIC 2 CERULOPLASMIN ASSAY— 510(k) K823107

Name: FDA 510(k) clearance K823107
Creator: U.S. Food and Drug Administration
Published: 1982-11-16

Substantially Equivalent

Kallestad Laboratories, Inc.

FDA 510(k) clearance K823107 for QUANTIMETRIC 2 CERULOPLASMIN ASSAY, Substantially Equivalent on 1982-11-16. Applicant: Kallestad Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Kallestad Laboratories, Inc.
Product code: Code DDB
Device class: Class 2
Regulation: 21 CFR 866.5210
Advisory panel: Immunology
Date received: 1982-10-21
Decision date: 1982-11-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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