FDA 510(k) Application Details - K930422

Device Classification Name Antiparietal Antibody, Indirect Immunofluorescent, Antigen, Control

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510(K) Number K930422
Device Name Antiparietal Antibody, Indirect Immunofluorescent, Antigen, Control
Applicant ELIAS USA, INC.
373 280TH ST.
OSCEOLA, WI US
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Contact GOTTFRIED KELLERMANN
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Regulation Number 866.5110

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Classification Product Code DBJ
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Date Received 01/26/1993
Decision Date 08/03/1993
Decision SE - Substantially Equivalent
Classification Advisory Committee IM - Immunology
Review Advisory Committee IM - Immunology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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