HEMOPEXIN NEPHELOMETRIC ASSAYS— 510(k) K780250

Name: FDA 510(k) clearance K780250
Creator: U.S. Food and Drug Administration
Published: 1978-02-28

Substantially Equivalent

Kallestad Laboratories, Inc.

FDA 510(k) clearance K780250 for HEMOPEXIN NEPHELOMETRIC ASSAYS, Substantially Equivalent on 1978-02-28. Applicant: Kallestad Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Kallestad Laboratories, Inc.
Product code: Code CZX
Device class: Class 2
Regulation: 21 CFR 866.5490
Advisory panel: Immunology
Date received: 1978-02-14
Decision date: 1978-02-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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