GDS ENZYMATIC THEOPHYLLINE REAGENT— 510(k) K891761

Name: FDA 510(k) clearance K891761
Creator: U.S. Food and Drug Administration
Published: 1989-05-16

Substantially Equivalent

Gds Diagnostics

FDA 510(k) clearance K891761 for GDS ENZYMATIC THEOPHYLLINE REAGENT, Substantially Equivalent on 1989-05-16. Applicant: Gds Diagnostics. Device class: 2.

Clearance details

Applicant: Gds Diagnostics
Product code: Code LCY
Device class: Class 2
Regulation: 21 CFR 862.3880
Advisory panel: Clinical Toxicology
Date received: 1989-03-24
Decision date: 1989-05-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elkhart, IN, US

Download summary PDF View on FDA.gov ↗

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