COMBINED GLUCOSE AND BUN STANDARDS— 510(k) K802825

Substantially Equivalent

Mallinckrodt Critical Care

FDA 510(k) clearance K802825 for COMBINED GLUCOSE AND BUN STANDARDS, Substantially Equivalent on 1980-12-11. Applicant: Mallinckrodt Critical Care. Device class: 2.

Clearance details

Applicant
Mallinckrodt Critical Care
Product code
Code JIX
Device class
Class 2
Regulation
21 CFR 862.1150
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
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