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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Activated Whole Blood Clotting Time
510(k) Number K971935
Device Name B&D ACTIVATED CLOTTING TIME (ACT) TEST TUBES BD-C101 (DIATOMACEOUS EARTH) AND BD-K101 (KAOLIN)
Applicant
B & D Corp.
14 Michael Dr.
Metuchen,  NJ  08840
Applicant Contact LADISLAU BIRO
Correspondent
B & D Corp.
14 Michael Dr.
Metuchen,  NJ  08840
Correspondent Contact LADISLAU BIRO
Regulation Number864.7140
Classification Product Code
JBP  
Date Received05/27/1997
Decision Date 10/01/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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