LUMATAG(TM) FERRITIN CHEMILUMINESCENCE IMMUNOMET.— 510(k) K901075
Substantially EquivalentLondon Diagnostics, Inc.
FDA 510(k) clearance K901075 for LUMATAG(TM) FERRITIN CHEMILUMINESCENCE IMMUNOMET., Substantially Equivalent on 1990-04-02. Applicant: London Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- London Diagnostics, Inc.
- Product code
- Code DBF
- Device class
- Class 2
- Regulation
- 21 CFR 866.5340
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Eden Prairie, MN, US
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