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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Vacuum Sample, With Anticoagulant
510(k) Number K921636
Device Name VACUTAINER(R) BRAND SAFETY-LOK BLOOD COLLECT SET
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
1 Becton Dr.
Franklin Lakes,  NJ  07417
Applicant Contact J ARNSBERGER
Correspondent
Bd Becton Dickinson Vacutainer Systems Preanalytic
1 Becton Dr.
Franklin Lakes,  NJ  07417
Correspondent Contact J ARNSBERGER
Regulation Number862.1675
Classification Product Code
GIM  
Date Received04/06/1992
Decision Date 04/29/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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