INDIRECT FLUORESCENCE ASSAY FOR ANTI-NATIVE DNA IGG ANTIBODY— 510(k) K990916
Substantially EquivalentStellar Bio Systems, Inc.
FDA 510(k) clearance K990916 for INDIRECT FLUORESCENCE ASSAY FOR ANTI-NATIVE DNA IGG ANTIBODY, Substantially Equivalent on 1999-04-21. Applicant: Stellar Bio Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Stellar Bio Systems, Inc.
- Product code
- Code KTL
- Device class
- Class 2
- Regulation
- 21 CFR 866.5100
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Columbia, MD, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.