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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Aggregrometer, Platelet
510(k) Number K851025
Device Name AGGRO/LINK COMPUTER INTERFACE
Applicant
Chrono-Log Corp.
2 W. Park Rd.
Havertown,  PA  19083
Applicant Contact ARTHUR FREILICH
Correspondent
Chrono-Log Corp.
2 W. Park Rd.
Havertown,  PA  19083
Correspondent Contact ARTHUR FREILICH
Regulation Number864.6675
Classification Product Code
JBX  
Date Received03/11/1985
Decision Date 06/12/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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