MEDICA INDIRECT IMMUNOFLUORESCENCE (IIF) ANTI- ENDOMYSIAL ANTIBODY (AEMA) TEST KIT, MODEL 6001-ESD— 510(k) K993034
Substantially EquivalentMedica, Inc.
FDA 510(k) clearance K993034 for MEDICA INDIRECT IMMUNOFLUORESCENCE (IIF) ANTI- ENDOMYSIAL ANTIBODY (AEMA) TEST KIT, MODEL 6001-ESD, Substantially Equivalent on 1999-11-01. Applicant: Medica, Inc.. Device class: 2.
Clearance details
- Applicant
- Medica, 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
- Encinitas, CA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.