FDA 510(k) Application Details - K935307

Device Classification Name Antigen, Antiserum, Control, Antithrombin Iii

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510(K) Number K935307
Device Name Antigen, Antiserum, Control, Antithrombin Iii
Applicant BAXTER DIAGNOSTICS, INC.
P.O. BOX 520672
MIAMI, FL US
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Contact RADAMES RIESGO
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Regulation Number 864.7060

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Classification Product Code DDQ
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Date Received 11/02/1993
Decision Date 11/22/1994
Decision SE - Substantially Equivalent
Classification Advisory Committee HE - Hematology
Review Advisory Committee HE - Hematology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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