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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Thrombin Time
510(k) Number K845000
Device Name THROMBINEX BOVINE THROMBIN
Applicant
Bio/Data Corp.
3615 Davisville Rd.
P.O. Box 250
Hatboro,  PA  19040
Applicant Contact JAMES W EICHELBERGE
Correspondent
Bio/Data Corp.
3615 Davisville Rd.
P.O. Box 250
Hatboro,  PA  19040
Correspondent Contact JAMES W EICHELBERGE
Regulation Number864.7875
Classification Product Code
GJA  
Date Received12/26/1984
Decision Date 03/26/1985
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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