HEMOPEXIN NEPHELOMETRIC ASSAY— 510(k) K801432

Name: FDA 510(k) clearance K801432
Creator: U.S. Food and Drug Administration
Published: 1980-07-08

Substantially Equivalent

J.T. Baker Chemical Co.

FDA 510(k) clearance K801432 for HEMOPEXIN NEPHELOMETRIC ASSAY, Substantially Equivalent on 1980-07-08. Applicant: J.T. Baker Chemical Co.. Device class: 2.

Clearance details

Applicant: J.T. Baker Chemical Co.
Product code: Code CZX
Device class: Class 2
Regulation: 21 CFR 866.5490
Advisory panel: Immunology
Date received: 1980-06-18
Decision date: 1980-07-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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