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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 K960860
Device Name GREINER VACUETTE BLOOD COLLECTION TUBE E/EDTA K3
Applicant
Greiner America, Inc.
7 Henry Ct.
Wilmington,  DE  19808
Applicant Contact ED MAIER
Correspondent
Greiner America, Inc.
7 Henry Ct.
Wilmington,  DE  19808
Correspondent Contact ED MAIER
Regulation Number862.1675
Classification Product Code
JKA  
Date Received03/01/1996
Decision Date 09/05/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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