FDA 510(k) Application Details - K780012

Device Classification Name Antigen, Antiserum, Control, Antithrombin Iii

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510(K) Number K780012
Device Name Antigen, Antiserum, Control, Antithrombin Iii
Applicant RIA DIAGNOSTICS

, US
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Regulation Number 864.7060

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Classification Product Code DDQ
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Date Received 01/03/1978
Decision Date 01/20/1978
Decision SE - Substantially Equivalent
Classification Advisory Committee HE - Hematology
Review Advisory Committee HE - Hematology
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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