TISSUE GRAM STAIN— 510(k) K864531
Substantially EquivalentSigma Diagnostics, Inc.
FDA 510(k) clearance K864531 for TISSUE GRAM STAIN, Substantially Equivalent on 1986-12-22. Applicant: Sigma Diagnostics, Inc..
Clearance details
- Applicant
- Sigma Diagnostics, Inc.
- Product code
- Code ICF
- Advisory panel
- Hematology
- 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.