ImmuLisa Enhanced Gliadin IgA Antibody ELISA, ImmuLisa Enhanced Gliadin IgG Antibody ELISA— 510(k) K163177
Substantially EquivalentImmco Diagnostics, Inc.
FDA 510(k) clearance K163177 for ImmuLisa Enhanced Gliadin IgA Antibody ELISA, ImmuLisa Enhanced Gliadin IgG Antibody ELISA, Substantially Equivalent on 2017-07-28. Applicant: Immco Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Immco Diagnostics, Inc.
- Product code
- Code MST
- Device class
- Class 2
- Regulation
- 21 CFR 866.5750
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Clarence, NY, US
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