NO. 1000-H FOR IMMUNOFLUOROMETRIC DETER. OF (ANA)— 510(k) K874115
Substantially EquivalentSigma Diagnostics, Inc.
FDA 510(k) clearance K874115 for NO. 1000-H FOR IMMUNOFLUOROMETRIC DETER. OF (ANA), Substantially Equivalent on 1987-11-04. Applicant: Sigma Diagnostics, Inc..
Clearance details
- Applicant
- Sigma Diagnostics, Inc.
- Product code
- Code LKJ
- Advisory panel
- Immunology
- 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.