LSA 290 ASSAY REAGENTS/NEPHELOMETRIC— 510(k) K801909

Name: FDA 510(k) clearance K801909
Creator: U.S. Food and Drug Administration
Published: 1980-09-26

Substantially Equivalent

J.T. Baker Chemical Co.

FDA 510(k) clearance K801909 for LSA 290 ASSAY REAGENTS/NEPHELOMETRIC, Substantially Equivalent on 1980-09-26. Applicant: J.T. Baker Chemical Co.. Device class: 1.

Clearance details

Applicant: J.T. Baker Chemical Co.
Product code: Code DEX
Device class: Class 1
Regulation: 21 CFR 866.5420
Advisory panel: Immunology
Date received: 1980-08-11
Decision date: 1980-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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