FDA 510(k) Application Details - K170509

Device Classification Name

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510(K) Number K170509
Device Name BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM Control Set
Applicant Bio-Rad Laboratories
5500 East Second Street
Benicia, CA 94510 US
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Contact Arlene Carillo
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Regulation Number

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Classification Product Code PUQ
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Date Received 02/21/2017
Decision Date 05/19/2017
Decision SESE - SUBST EQUIV
Classification Advisory Committee MI - Microbiology
Review Advisory Committee MI - Microbiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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