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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Automated Platelet Aggregation
510(k) Number K161329
Device Name Chrono-log Platelet Aggregometer, 4 channel; Chrono-log Platelet Aggregometer, 8 channel
Applicant
Chrono-Log Corp.
2 W. Park Rd.
Havertown,  PA  19083
Applicant Contact Nicholas J Veriabo
Correspondent
Chrono-Log Corp.
2 W. Park Rd.
Havertown,  PA  19083
Correspondent Contact Nicholas J Veriabo
Regulation Number864.5700
Classification Product Code
JOZ  
Date Received05/12/2016
Decision Date 12/02/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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