GLUCOSE REAGENT (O-TOLUIDINE)— 510(k) K771314

Name: FDA 510(k) clearance K771314
Creator: U.S. Food and Drug Administration
Published: 1977-08-03

Substantially Equivalent

Mallinckrodt Critical Care

FDA 510(k) clearance K771314 for GLUCOSE REAGENT (O-TOLUIDINE), Substantially Equivalent on 1977-08-03. Applicant: Mallinckrodt Critical Care. Device class: 2.

Clearance details

Applicant: Mallinckrodt Critical Care
Product code: Code CGE
Device class: Class 2
Regulation: 21 CFR 862.1345
Advisory panel: Clinical Chemistry
Date received: 1977-07-18
Decision date: 1977-08-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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