K001403
Substantially EquivalentSIGMA DIAGNOSTICS INFINITY GLUCOSE REAGENT, MODELS 17-25, 17-100P, 17-500P, 17-2000P, 18-20, 18-100P
- Applicant
- Sigma Diagnostics, Inc.
- Product code
- CFR
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- St. Louis, MO, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.