GDS ENZYMATIC B-HYDROXYBUTYRATE REAGENT MODIFIED— 510(k) K910108

Substantially Equivalent

Gds Diagnostics

FDA 510(k) clearance K910108 for GDS ENZYMATIC B-HYDROXYBUTYRATE REAGENT MODIFIED, Substantially Equivalent on 1991-03-04. Applicant: Gds Diagnostics.

Clearance details

Applicant: Gds Diagnostics
Product code: 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.