FDA 510(k) Application Details - K972257

Device Classification Name Antigen, Antiserum, Control, Antithrombin Iii

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510(K) Number K972257
Device Name Antigen, Antiserum, Control, Antithrombin Iii
Applicant CRESTAT DIAGNOSTICS, INC.
374 GOODHILL RD.
WESTON, CT 06883 US
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Contact MARY REES
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Regulation Number 864.7060

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Classification Product Code DDQ
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Date Received 06/17/1997
Decision Date 10/20/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee HE - Hematology
Review Advisory Committee HE - Hematology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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