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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tubes, vials, systems, serum separators, blood collection
510(k) Number K921806
Device Name VACUTAINER(R) BRAND SST(R) AND CAT TUBES
Applicant
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
1 BECTON DR.
FRANKLIN LAKES,  NJ  07417 -1880
Applicant Contact J ARNSBERGER
Correspondent
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
1 BECTON DR.
FRANKLIN LAKES,  NJ  07417 -1880
Correspondent Contact J ARNSBERGER
Regulation Number862.1675
Classification Product Code
JKA  
Date Received04/15/1992
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
Recalls CDRH Recalls
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