GILCHEM Y-GT REAGENT— 510(k) K822149

Substantially Equivalent

Gilford Diagnostics

FDA 510(k) clearance K822149 for GILCHEM Y-GT REAGENT, Substantially Equivalent on 1982-08-12. Applicant: Gilford Diagnostics. Device class: 1.

Clearance details

Applicant
Gilford Diagnostics
Product code
Code JPZ
Device class
Class 1
Regulation
21 CFR 862.1360
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
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