FDA 510(k) Application Details - K864877

Device Classification Name System, Test, Carcinoembryonic Antigen

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510(K) Number K864877
Device Name System, Test, Carcinoembryonic Antigen
Applicant CIBA CORNING DIAGNOSTICS CORP.
333 CONEY ST.
E. WALPOLE, MA US
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Contact SCHAEFER, PHD
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Regulation Number 866.6010

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Classification Product Code DHX
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Date Received 12/12/1986
Decision Date 05/21/1987
Decision SE - Substantially Equivalent
Classification Advisory Committee IM - Immunology
Review Advisory Committee IM - Immunology
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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