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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reagent, Platelet Aggregation
510(k) Number K922800
Device Name PLATELET AGGREGATION REAGENTS
Applicant
Chrono-Log Corp.
2 W. Park Rd.
Havertown,  PA  19083
Applicant Contact AURTHUR FREILICH
Correspondent
Chrono-Log Corp.
2 W. Park Rd.
Havertown,  PA  19083
Correspondent Contact AURTHUR FREILICH
Regulation Number864.5700
Classification Product Code
GHR  
Date Received06/10/1992
Decision Date 08/26/1992
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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