ANTI DS-DNA— 510(k) K943291
Substantially EquivalentSigma Diagnostics, Inc.
FDA 510(k) clearance K943291 for ANTI DS-DNA, Substantially Equivalent on 1994-12-02. Applicant: Sigma Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Sigma Diagnostics, Inc.
- Product code
- Code LLL
- Device class
- Class 2
- Regulation
- 21 CFR 866.5100
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- St. Louis, MO, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.