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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Time, Partial Thromboplastin
510(k) Number K873382
Device Name PLATELET EXTRACT REAGENT
Applicant
Bio/Data Corp.
3615 Davisville Rd.
P.O. Box 250
Hatboro,  PA  19040
Applicant Contact JAMES EICHELBERGER
Correspondent
Bio/Data Corp.
3615 Davisville Rd.
P.O. Box 250
Hatboro,  PA  19040
Correspondent Contact JAMES EICHELBERGER
Regulation Number864.7925
Classification Product Code
GGW  
Date Received08/24/1987
Decision Date 11/20/1987
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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