ImmuLisa Enhanced B2GP1 IgA Antibody ELISA, ImmuLisa Enhanced B2GP1 IgG Antibody ELISA, ImmuLisa Enhanced B2GP1 IgM Antibody ELISA, ImmuLisa Enhanced B2GP1 IgA/IgG/IgM Antibody ELISA— 510(k) K162788
Substantially EquivalentImmco Diagnostics, Inc.
FDA 510(k) clearance K162788 for ImmuLisa Enhanced B2GP1 IgA Antibody ELISA, ImmuLisa Enhanced B2GP1 IgG Antibody ELISA, ImmuLisa Enhanced B2GP1 IgM Antibody ELISA, ImmuLisa Enhanced B2GP1 IgA/IgG/IgM Antibody ELISA, Substantially Equivalent on 2017-06-19. Applicant: Immco Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Immco Diagnostics, Inc.
- Product code
- Code MSV
- Device class
- Class 2
- Regulation
- 21 CFR 866.5660
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Clarence, NY, US
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More clearances from Immco Diagnostics, Inc.
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Data sourced from openFDA. This site is unofficial and independent of the FDA.