IMMULISA CELIAC TTG IGA AND IGG ANTIBODY ELISA— 510(k) K091520
Substantially EquivalentImmco Diagnostics, Inc.
FDA 510(k) clearance K091520 for IMMULISA CELIAC TTG IGA AND IGG ANTIBODY ELISA, Substantially Equivalent on 2010-03-10. Applicant: Immco Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Immco Diagnostics, Inc.
- Product code
- Code MVM
- Device class
- Class 2
- Regulation
- 21 CFR 866.5660
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Buffalo, NY, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.