BAKER DIAG. ULTRARATE CO2 REAGENT KIT— 510(k) K802035

Name: FDA 510(k) clearance K802035
Creator: U.S. Food and Drug Administration
Published: 1980-09-26

Substantially Equivalent

J.T. Baker Chemical Co.

FDA 510(k) clearance K802035 for BAKER DIAG. ULTRARATE CO2 REAGENT KIT, Substantially Equivalent on 1980-09-26. Applicant: J.T. Baker Chemical Co.. Device class: 2.

Clearance details

Applicant: J.T. Baker Chemical Co.
Product code: Code JFL
Device class: Class 2
Regulation: 21 CFR 862.1160
Advisory panel: Clinical Chemistry
Date received: 1980-08-22
Decision date: 1980-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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