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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 K781807
Device Name REAGENT, FIREFLY #395
Applicant
Chrono-Log Corp.
2 W. Park Rd.
Havertown,  PA  19083
Applicant Contact Arthur Frelich
Correspondent
Chrono-Log Corp.
2 W. Park Rd.
Havertown,  PA  19083
Correspondent Contact Arthur Frelich
Regulation Number864.5700
Classification Product Code
JOZ  
Date Received10/25/1978
Decision Date 11/22/1978
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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