ANTINUCLEAR ANTIBODY IMMUNOGLOBULIN TEST SYSTEM— 510(k) K914550
Substantially EquivalentDiagnostic Resources, Inc.
FDA 510(k) clearance K914550 for ANTINUCLEAR ANTIBODY IMMUNOGLOBULIN TEST SYSTEM, Substantially Equivalent on 1992-02-11. Applicant: Diagnostic Resources, Inc.. Device class: 2.
Clearance details
- Applicant
- Diagnostic Resources, Inc.
- Product code
- Code LKJ
- Device class
- Class 2
- Regulation
- 21 CFR 866.5100
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Aurora, CO, US
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