ALBUMIN NEPHELOMETRIC ASSAY— 510(k) K801362

Name: FDA 510(k) clearance K801362
Creator: U.S. Food and Drug Administration
Published: 1980-07-21

Substantially Equivalent

J.T. Baker Chemical Co.

FDA 510(k) clearance K801362 for ALBUMIN NEPHELOMETRIC ASSAY, Substantially Equivalent on 1980-07-21. Applicant: J.T. Baker Chemical Co.. Device class: 1.

Clearance details

Applicant: J.T. Baker Chemical Co.
Product code: Code JQX
Device class: Class 1
Regulation: 21 CFR 862.2700
Advisory panel: Clinical Chemistry
Date received: 1980-06-09
Decision date: 1980-07-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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