COMPLEMENT C4 NEPHELOMETRIC ASSAY— 510(k) K801361

Name: FDA 510(k) clearance K801361
Creator: U.S. Food and Drug Administration
Published: 1980-06-30

Substantially Equivalent

J.T. Baker Chemical Co.

FDA 510(k) clearance K801361 for COMPLEMENT C4 NEPHELOMETRIC ASSAY, Substantially Equivalent on 1980-06-30. Applicant: J.T. Baker Chemical Co.. Device class: 2.

Clearance details

Applicant: J.T. Baker Chemical Co.
Product code: Code DBI
Device class: Class 2
Regulation: 21 CFR 866.5240
Advisory panel: Immunology
Date received: 1980-06-09
Decision date: 1980-06-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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