LONDON DIAGNOSTICS LUMATAG (R) IGE CHEM. IMM ASSAY— 510(k) K903195
Substantially EquivalentLondon Diagnostics, Inc.
FDA 510(k) clearance K903195 for LONDON DIAGNOSTICS LUMATAG (R) IGE CHEM. IMM ASSAY, Substantially Equivalent on 1990-08-02. Applicant: London Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- London Diagnostics, Inc.
- Product code
- Code DGC
- Device class
- Class 2
- Regulation
- 21 CFR 866.5510
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Eden Prairie, MN, US
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