K910108

Substantially Equivalent

GDS ENZYMATIC B-HYDROXYBUTYRATE REAGENT MODIFIED

Applicant: Gds Diagnostics
Product code: JIN
Advisory panel: Clinical Chemistry
Date received: 1991-01-10
Decision date: 1991-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elkhart, IN, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.