FDA 510(k) Application Details - K222439

Device Classification Name Radioimmunoassay, Vancomycin

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510(K) Number K222439
Device Name Radioimmunoassay, Vancomycin
Applicant Siemens Healthcare Diagnostics Inc.
511 Benedict Avenue
Tarrytown, NY 10591 US
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Contact Joy Anoop
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Regulation Number 862.3950

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Classification Product Code LEH
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Date Received 08/12/2022
Decision Date 08/08/2023
Decision SESE - SUBST EQUIV
Classification Advisory Committee TX - Clinical Toxicology
Review Advisory Committee TX - Clinical Toxicology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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