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FDA 510(k)

MEDICA INDIRECT IMMUNOFLUORESCENCE (IIF) ANTI- ENDOMYSIAL ANTIBODY (AEMA) TEST KIT, MODEL 6001-ESD

K-Number: K993034 · 1999-11-01

ApplicantMedica, Inc.
Decision Date1999-11-01
Product CodeMVM
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

MEDICA INDIRECT IMMUNOFLUORESCENCE (IIF) ANTI- ENDOMYSIAL ANTIBODY (AEMA) TEST KIT, MODEL 6001-ESD is the device name listed in this FDA 510(k) record. The listed applicant is Medica, Inc.. It received FDA 510(k) clearance on 1999-11-01 under 510(k) number K993034. The device is classified under product code MVM. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDICA INDIRECT IMMUNOFLUORESCENCE (IIF) ANTI- ENDOMYSIAL ANTIBODY (AEMA) TEST KIT, MODEL 6001-ESD?

MEDICA INDIRECT IMMUNOFLUORESCENCE (IIF) ANTI- ENDOMYSIAL ANTIBODY (AEMA) TEST KIT, MODEL 6001-ESD is a medical device that received FDA 510(k) clearance on 1999-11-01. The listed applicant is Medica, Inc.. The 510(k) number is K993034.

When did MEDICA INDIRECT IMMUNOFLUORESCENCE (IIF) ANTI- ENDOMYSIAL ANTIBODY (AEMA) TEST KIT, MODEL 6001-ESD receive FDA 510(k) clearance?

MEDICA INDIRECT IMMUNOFLUORESCENCE (IIF) ANTI- ENDOMYSIAL ANTIBODY (AEMA) TEST KIT, MODEL 6001-ESD received FDA 510(k) clearance on 1999-11-01, under 510(k) number K993034.

Who is the listed applicant for MEDICA INDIRECT IMMUNOFLUORESCENCE (IIF) ANTI- ENDOMYSIAL ANTIBODY (AEMA) TEST KIT, MODEL 6001-ESD?

The FDA 510(k) record lists Medica, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEDICA INDIRECT IMMUNOFLUORESCENCE (IIF) ANTI- ENDOMYSIAL ANTIBODY (AEMA) TEST KIT, MODEL 6001-ESD?

The FDA product code for MEDICA INDIRECT IMMUNOFLUORESCENCE (IIF) ANTI- ENDOMYSIAL ANTIBODY (AEMA) TEST KIT, MODEL 6001-ESD is MVM.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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