GDS ENZYMATIC THEOPHYLLINE REAGENT— 510(k) K891761
Substantially EquivalentGds Diagnostics
FDA 510(k) clearance K891761 for GDS ENZYMATIC THEOPHYLLINE REAGENT, Substantially Equivalent on 1989-05-16. Applicant: Gds Diagnostics.
Clearance details
- Applicant
- Gds Diagnostics
- Product code
- Code LCY
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Elkhart, IN, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.