FDA 510(k) Application Details - K032951

Device Classification Name System, Automated Platelet Aggregation

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510(K) Number K032951
Device Name System, Automated Platelet Aggregation
Applicant CHRONO-LOG CORP.
2 WEST PARK RD.
HAVERTOWN, PA 19083 US
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Contact NICHOLAS J VERIABO
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Regulation Number 864.5700

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Classification Product Code JOZ
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Date Received 09/22/2003
Decision Date 04/02/2004
Decision SESE - SUBST EQUIV
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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