GLUCOSE (HK) REAGENT, UNIVERSAL— 510(k) K905227

Substantially Equivalent

Enzyme Technology, Inc.

FDA 510(k) clearance K905227 for GLUCOSE (HK) REAGENT, UNIVERSAL, Substantially Equivalent on 1991-03-11. Applicant: Enzyme Technology, Inc.. Device class: 2.

Clearance details

Applicant
Enzyme Technology, Inc.
Product code
Code CFR
Device class
Class 2
Regulation
21 CFR 862.1345
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Shelton, CT, US
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